MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number NEU_ENS_STIMULATOR

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 02/11/2016

Event Type  Injury  

Manufacturer Narrative

Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.Please note that this date is based off the date the article was accepted for publication as the actual event date was not provided.Information references the main component of one of the systems involved in the reported events; other applicable components are: product id: neu_unknown_lead, lot# unknown, product type: lead.These events occurred in (b)(6).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Banakhar m, hassouna m.Percutaneous nerve evaluation test versus staged test trials for sacral neuromodulation: sensitivity, specificity, and predictive values of each technique.International neurourology journal.2016; 20: 250-254.Doi: (b)(4) summary: interstim device is an u.S.Food and drug administration approved minimal invasive therapy for sacral neuromodulation for lower urinary tract dysfunction.Before interstim implantation, a trial with the appropriate screening tests is required to determine patient therapy eligibility.There are two different techniques for patient screening: percutaneous nerve evaluation (pne) test and staged test.Few studies have reported success and failure rates for each technique.However, test sensitivity and predictive values of either test have not been studied.The aim of our study was to determine the sensitivity and specificity of each test and to establish a decision algorithm for the most appropriate testing method to be used as a screening test.Reported events: 10 patients with lower urinary tract dysfunction required staged testing for sacral neuromodulation (snm) due to no response or technical difficulty, such as lead migration, during the peripheral nerve evaluation (pne).The author stated that if any difficulty was encountered during pne testing (i.E.Patient could not tolerate the procedure under local anesthesia, difficult foramen localization), then the patient was selected for a staged test trial.It was also noted that patients who demonstrated no response and presented no sensation at all, or for whom sensation diminished after a while, or location of sensation had changed, additional sacral radiograms (anterior-posterior and lateral views) were obtained in order to diagnose electrode migration; if this was confirmed, the patients underwent staged procedure.It was unclear how many patients required the staged procedure due to electrode migration as opposed to other procedure-related issues.The following device specifics were provided: unknown model interstim implantable neurostimulator; lead model 3889.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXTERNAL NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6223748
• MDR Text Key: 63911177
• Report Number: 3007566237-2017-00031
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: 12/09/2016
• Supplement Dates FDA Received: 09/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention