Axonics Entrance Practice Test

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• What is a typical range for SNM stimulation amplitude in milliamps (mA)?
• What is a surrogate endpoint? Give an example relevant to SNM.
• Which clinical outcome best reflects the therapeutic aim of SNM in overactive bladder?
• Trial length and stimulation parameters for SNM in urinary retention are well established.
• According to the American College of Gastroenterology, sacral nerve modulation is a strong recommendation for the treatment of fecal incontinence.
• Which measure indicates success with sacral neuromodulation for urinary retention?
• Which regulatory concept is defined by 21 CFR Part 803?
• Why is sterile technique crucial during implantation?
• Name two common risk controls used in sacral neuromodulation implantation.
• In the event of a device failure, what is the recommended escalation pathway?
• What does a 95% confidence interval mean in statistical terms?
• Which of the following best describes why sterile technique affects implant safety?
• Which neurotransmitter system primarily drives detrusor contraction?
• Which tissue is NOT listed as a soft tissue layer potentially covering the S3 foramen?
• In the context of data interpretation, what would a stable impedance reading across months suggest?
• Which of the following is NOT a key consideration in sterile processing of implantable devices?
• During lead testing for sacral neuromodulation, what is a key step?
• What is the typical purpose of an 'implantable pulse generator' (IPG) in SNM therapy?
• Which feature of Axonics SNM devices extends the interval between surgical replacements?
• Which muscle is NOT considered part of the anal sphincter complex?
• Which statement best describes 'remote programming' in Axonics SNM systems?
• What is the goal of human factors usability testing in medical devices?
• What is the first line of treatment in the patient care pathway for treatment of OAB according to guidelines?
• What is data integrity in clinical research?
• SNM therapy targets which nerves to influence bladder function?
• Sacral neuromodulation is on-label to treat all types of urinary retention.
• During SNM programming, which principle guides parameter selection?
• SNM stimulation amplitude is typically described as being what?
• Which muscles form the anal sphincter complex?
• Which component of the Axonics system stores stimulation parameters for patient use?
• What ducts carry urine from kidneys to the bladder?
• Define root cause analysis (RCA) and give a basic method.
• Which statement about sacral nerve modulation and fecal incontinence is supported by the material?
• Which regulatory body oversees medical devices in the United States?
• Which of the following is a common cause of obstructive urinary retention?
• The fibers that travel from the bladder to the brain are the:
• Which statement about the process of adjusting SNM therapy during titration is true?
• What smooth muscle forms the wall of the bladder?
• Electrical impedance testing in SNM devices helps detect what?
• Which of the following is a symptom of urinary retention?
• The Pontine Micturition Center is associated with controlling which aspects of urination?
• During testing for sacral neuromodulation, why is therapeutic response testing performed?
• Beyond symptom relief, which outcome is commonly monitored during programming to assess SNM effectiveness?
• What is a typical follow-up window for assessing sacral neuromodulation outcomes after implantation?
• In sacral nerve modulation therapy, how is the duty cycle defined?
• What is the PGI-I scale?
• In the software lifecycle for a medical device, which stage focuses on ensuring the product meets design inputs and user needs before release?
• Which design feature helps prevent accidental damage to implanted components during MRI?
• Which document or regulation governs post-market surveillance for medical devices in the US?
• During programming, which data point most directly indicates successful stimulation?
• Urge incontinence is best described as which of the following?
• What is the dominant innervation of the Detrusor?
• Which standard governs the software life cycle processes for medical devices?
• Sacral neuromodulation (SNM) is indicated for which of the following conditions?
• Which of the following is NOT one of the four core symptoms of overactive bladder?
• What is the role of regulatory submissions in post-market changes?
• What is the purpose of a power analysis?
• In a noninferiority trial, which statement correctly describes the analysis goal?
• What is the most direct effect of increasing stimulation amplitude in SNM?
• Dominant innervation for the bladder is through which type of activity?
• What is the typical clinical sign that leads to consideration of SNM therapy?
• Which of the following is NOT one of the four core symptoms of overactive bladder?
• Which of the following is NOT a first-line conservative therapy for overactive bladder?
• Compared with optimal medical management, sacral nerve modulation is at least as effective for fecal incontinence.
• What does ISO 13485 address in relation to medical devices?
• Which of the following are typical adverse events associated with sacral neuromodulation?
• Which statement correctly defines sensitivity and specificity?
• What clinical outcome would indicate a successful SNM trial before permanent implantation?
• Which of the following is NOT used to determine the S3 level on the lateral image?
• What is ISO 13485 and why is it relevant to medical devices?
• Which term describes a secondary outcome used as a proxy for a clinical outcome?
• What is hazard analysis in risk management?
• Which of the following is not a typical goal of device labeling and user instructions?
• Muscarinic receptors in the bladder primarily mediate which action?
• In impedance monitoring, which reading would most likely indicate a healthy lead contact?
• What is lead migration and why is it problematic?
• No sensation of bladder fullness is a symptom of urinary retention.
• The trigone of the bladder is formed by the openings of which structures?
• In programming for patient comfort, which parameter is typically adjusted first?
• Urinary retention is more common in men than in women.
• Which statement best describes the role of impedance testing prior to programming in sacral neuromodulation?
• How does Axonics ensure MRI compatibility for its SNM system?
• Which statement correctly differentiates FDA 510(k) clearance from Premarket Approval (PMA)?
• Which muscle group contracts during the pelvic floor bellows action?
• Which statement best describes intention-to-treat analysis?
• Which outcome is associated with sacral nerve modulation in patients with fecal incontinence?
• The Axonics INS is placed 4 cm below the iliac crest in the hollow of the ileum. Which bone region is this?
• What is source data verification (SDV) in clinical trials?
• Which of the following is NOT a factor influencing the battery life of an implantable neuromodulation device?
• What does ICH-GCP stand for and why is it relevant?
• What is the main distinction between a high-level risk assessment and a detailed FMEA?
• What is the role of impedance checks during clinic visits?
• Describe the software lifecycle stages for a medical device.
• Which adverse event is commonly monitored as a potential complication of sacral neuromodulation therapy?
• What is the least invasive treatment option for fecal incontinence?
• What is ISO 14971 and its purpose?
• There is LITTLE DATA supporting SNM for urinary retention.
• In device safety, what does 'electrical isolation' refer to?
• Which tissue safety consideration is particularly important for implanted neuromodulation leads?
• The small bumps on the anterior sacrum that correlate with the transverse lines or fusion plates are called what?
• Moving the C-ARM cephalad means moving toward the direction of the?
• If SNM device shows signs of malfunction, what is the recommended course of action?
• Urinary retention can be caused by both non-neurogenic and neurogenic etiologies.
• Urinary retention is defined by which condition?
• What practice helps ensure the long-term reliability of a rechargeable SNM system?
• What is one reason radiation safety is easily taken for granted?
• Which of the following is NOT typically considered a reportable SNM device adverse event?
• What is the primary purpose of MRI exposure guidelines in patients with SNM implants?
• Which statement best describes the FDA clearance pathways for medical devices, particularly 510(k) vs PMA?
• In SNM management, which of the following best describes the role of the external programmer?
• Which method is commonly used to verify proper lead placement during sacral neuromodulation implantation?
• The degree of sphincter defect is the main cause of fecal incontinence.
• Which statement about software verification and validation is most accurate?
• In a CAPA plan, which element is used to confirm that corrective actions have actually resolved the issue?
• In rechargeable SNM systems, which factor most influences battery longevity besides stimulation parameters?
• If a diagnostic test has high sensitivity, what does this imply about false negatives?
• What does PMCF stand for and entail?
• What are the three keys to radiation safety?
• Which of the following is listed as a potential cause of fecal incontinence?
• The Axonics INS should be located how far below the iliac crest?
• Why is long-term follow-up important after neuromodulation device implantation?
• Which structure is among the three key features to evaluate on SNM AP imaging?
• Approximately how many Americans are affected by overactive bladder?
• Abnormal communication between the bladder and the brain can be the results of which of the following?
• What is post-market surveillance (PMS) and why is it important?
• What is the primary purpose of a telemetry test in SNM device programming?
• What % of patients that are given a medication for AB, will discontinue it within 6 months?
• Which of the following is NOT an indication for sacral neuromodulation (SNM)?
• What is the primary anatomical target for sacral neuromodulation in Axonics therapy?
• In SNM AP imaging, which of the following is one of the three key structures?
• Where is the trigone located?
• Impedance monitoring helps determine lead health by indicating which of the following?
• Which patient factor is important when selecting SNM therapy?
• Which statement about biocompatibility testing is false?
• What is the difference between a rechargeable SNM system and a non-rechargeable one for patients?
• Which of the following is a factor in continence?
• Which of the following is a factor relating to nerve supply that contributes to continence?
• Which statement best defines per-protocol analysis?
• During the initial SNM activation, what is typically titrated to achieve the desired effect?
• Which statement best defines an adverse device event (ADE)?
• Which standard guides biocompatibility assessment for implanted medical devices?
• What is the main purpose of Failure Modes and Effects Analysis (FMEA) in risk management for medical devices?
• What maintenance difference exists for patients with non-rechargeable SNM systems?
• Which factor most influences battery longevity in a rechargeable SNM system?
• What is the triangular region at the base of the urinary bladder between the openings of the ureters and urethra called?
• There are typically how many posterior sacral foramina on each side for lead insertion?
• All of the following are factors contributing to continence EXCEPT.
• In hypothesis testing, what does a p-value indicate?
• Which term describes leakage that occurs when the bladder overfills?
• What is the expected patient outcome before considering hardware revision?
• If a stimulation pulse has a width of 210 microseconds and operates at 100 Hz, what is the duty cycle?
• Which data point is most valuable in judging long-term SNM efficacy?
• Which regulatory standard defines essential electrical safety for medical devices like Axonics implants?
• What is the purpose of titration curves in SNM programming?
• In data integrity, which characteristic ensures that data remains accurate over its entire lifecycle?
• Which condition is commonly considered for SNM therapy after failing conservative treatment?
• What is a typical symptom that SNM aims to reduce in patients with urinary incontinence?
• What is the primary goal of sacral neuromodulation therapy in Axonics devices?
• Stimulation of muscarinic receptors on the bladder most directly causes which response?
• Over months, a stable impedance reading most directly suggests what about the SNM system?
• What is the difference between a device-related adverse event and a patient-related adverse event?
• What are the two primary bladder receptors involved in bladder function?
• Which practice supports effective root cause analysis when a defect is found in a component?
• Injectable bulking agents are minimally invasive and have a high recommendation as an early treatment option for fecal incontinence.
• The detrusor muscle is which type of muscle?
• Overactive bladder impacts quality of life in all of the following domains EXCEPT:
• Overactive bladder is due to the bladder being lazy and not wanting to contract?
• Which sacral nerve root is primarily targeted by sacral neuromodulation to treat lower urinary tract symptoms?
• Which muscles contract in the bellows response?
• Which describes 'lead impedance drift' in Axonics SNM systems?
• What clinical information is most useful to determine if SNM therapy is effective during a programming visit?
• In SNM programming, what does the term 'on time' refer to?
• Which term describes an object that shows up clearly on X-ray due to high density?
• The bladder is the only WHAT TYPE OF muscle in the body that we gain WHAT TYPE control over?
• Approximately what percentage of patients discontinue overactive bladder medication within six months?
• Post-void fullness is a symptom of urinary retention.
• How is MRI safety addressed for implanted SNM devices?
• Which aspect of the sacroiliac joint is used as a landmark to identify the S3 foramen?
• CAPA in quality management stands for Corrective and Preventive Action. What is its purpose?
• What is a common method to monitor SNM device functioning overnight?
• Which considerations are essential in sterile processing of implantable devices?
• Which programming parameter most directly affects the perceived strength of stimulation?
• How many individual muscles make up the levator ani?
• Which component delivers controlled electrical pulses to the sacral nerves in SNM therapy?
• Which features are used to determine the level of S3 in the lateral image?
• Biocompatibility testing assesses tissue compatibility; name two common tests.
• Which of the following statements about continence factors is true?
• What is the purpose of impedance testing in sacral neuromodulation?
• What is the main purpose of lead integrity monitoring in SNM systems?
• Why is software validation essential in implantable medical devices?
• Which gender is more commonly affected by urinary retention?
• What Center controls storage and void of urine?
• What is the clinical rationale for using sacral neuromodulation (SNM) therapy in overactive bladder?
• What does CE marking indicate for a medical device?
• Which three structures are the most important to identify on SNM AP x-ray images?
• What does FMEA stand for and what is its purpose?
• Which statement best reflects considerations when selecting lead placement for sacral neuromodulation?
• Moving the C-ARM toward the feet is called?
• Which organization is cited as supporting sacral nerve modulation as a strong treatment option for fecal incontinence?
• Which of the following is NOT a side effect of overactive bladder medications?
• An impedance measurement of 700 ohms is most consistent with which assessment?
• What is a noninferiority trial?
• Long-term use of some medications is a listed cause of obstructive urinary retention.
• The shadow of the greater sciatic notch is a useful landmark to help locate which sacral foramen?
• Urge incontinence results from increases in intra-abdominal pressure that are transmitted to the bladder that pushes the urine out?
• What does telemetry refer to in SNM devices?
• Muscarinic receptors are responsible for what in the bladder?
• Urge incontinence is best described as a sudden, compelling urge to urinate that leads to involuntary urine loss.
• ISO 14971 covers which critical activity in medical device risk management?
• Sacral Neuromodulation electrically stimulates which nerves in the sacral spinal root?
• A metallic object such as a surgical implant or tied lead marker will show as WHAT on an ×-ray image?
• Which test may help distinguish a device fault from patient nonresponse during programming?
• What should a corrective action plan in CAPA typically include?
• Symptomatic chronic urinary retention (CUR) is defined by which of the following?
• What is a standard first step in troubleshooting when a patient reports no stimulation?
• What is the purpose of sterile labeling and packaging validation?
• What endpoints are commonly used in sacral neuromodulation trials for overactive bladder?
• Bladder emptying is mediated by the stimulation of muscarinic receptors in the brain?
• What is the purpose of device labeling and user instructions?
• CE marking stands for Conformité Européenne and indicates compliance with what?
• In clinical practice, which adverse event should be promptly reported for SNM devices?
• Fecal incontinence is defined as the involuntary loss of liquid or solid stool that causes a social or hygiene problem.
• Sacral nerve modulation has been proven to be effective for fecal incontinence and improves quality of life.
• Why is patient education on charging important for Axonics rechargeable systems?
• ISO 13485 applies to what aspect of the Axonics product lifecycle?
• What is a common reason for post-implant follow-up visits after SNM therapy?
• What is the primary mechanism by which sacral neuromodulation modulates bladder activity?
• Muscarinic receptors relevant to bladder function are primarily located in which tissue?
• Which regulatory pathway is commonly used for class III medical devices in the United States?
• Which statement about risk management in medical devices is true?
• Which statement about risk assessment approaches is true?
• How does post-implant follow-up typically proceed in SNM therapy?
• What does the term 'titration' refer to in SNM programming?
• If a test has high specificity, what does this imply about false positives?
• Which clinical measurement is often used to evaluate SNM impact on bladder function?
• In SNM therapy, which statement best describes the role of patient diaries?
• How do hazard analysis and risk assessment differ?