MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 353101

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Pain (1994); Skin Irritation (2076); Complaint, Ill-Defined (2331); Fluid Discharge (2686)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 978b128, lot#: unknown, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a trial patient who was using an external neurostimulator (ens) for urge incontinence.It was reported that the patient stated she is still leaking on herself and leaks all the time.There were no device issues reported, and no further patient complications are anticipated or expected as a result of this event.Additional information was received from a consumer via a manufacturer representative.It was reported that the patient's urgency is still bad and it causes her to leak.The patient mentioned their device is not working.The patient did not have their programmer with them.On (b)(6) 2020, they said they probably have an infection at the incision site, there was an odor and a lot of fluid draining.The patient had a lot of pain around their incision site area.Their condition is worsening since yesterday.On (b)(6) 2020, the manufacturer representative (rep) called and is currently with the patient who received a message that stated "invalid cable - test stimulation cable cannot be used for this workflow" - caller attempted to replace the ens twice but issue was not resolved.The caller indicated that they were unable to replace the cable due to buried extension.The caller did indicate the cable may have been exposed to bodily fluid and may try to work on it by drying it off.On (b)(6) 2020, the patient stated the lead wire has come loose from the nerve and has to be re-positioned.They are waiting to hear from their clinician as to when and what they will do.The patient also broke out.

Manufacturer Narrative

Continuation of d11: product id 978b128 lot# unknown product type lead.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that the cause of the device not working was unknown but most likely bodily fluid or water from bathing infiltrated the ins and perc extension.The steps taken to resolve the device not working were the manufacture representative tried changing the batteries in the ens but that didn¿t work.They replaced the ens and received the error message regarding the perc extension being invalid.The rep called technical services for a work around, but no solution was available since the extension wire connects under the skin in a sterile environment.Bodily fluid/water are most likely the cause of the invalid cable notification.The steps taken to resolve the lead wire came loose from the nerve and had to be re-positioned were the lead wires was not loose.The patient thought the perc extension and lead wire were one and the same.It was said that the ens and external portion of the perc extension were discarded.The patient¿s backside was re-dressed to pro tect against potential infection.The physician is treating the skin irritation with antibiotics and think the patient had an unknown reaction to either the adhesive or prep solution.The patient and physician were going to decide to either implant on 9/25 or re-do an advanced evaluation.

Event Description

Additional information was received from a manufacturer representative (rep).In response to the inquiry for if the lead had needed to be repositioned, the rep replied that the lead had been where they had initially implanted it so no revision was required.No further complications were reported at this time.

Manufacturer Narrative

Continuation of d11: product id: 3560022, product type: extension.Other relevant device(s) are: product id: 3560022, product type: extension.H6: prior submitted device code c62917 no longer applies to this report prior submitted device referenced in d11 & h10 of past reports: product id: 978b128.No longer applies to this report.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10543548
• MDR Text Key: 207733167
• Report Number: 2182207-2020-00897
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2020

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: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 09/17/2020; 09/17/2020
• Supplement Dates FDA Received: 09/29/2020; 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR