MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Break (1069); Failure to Deliver Energy (1211); Energy Output Problem (1431); Difficult to Remove (1528); Environmental Compatibility Problem (2929); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Discomfort (2330); Dysuria (2684); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Date is estimated; month and year are valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the reason for the call was that the patient had surgery on the (b)(6) (no indication related to device/therapy), and stated the night before the surgery, they had turned the ins off and "the next day," they turned the ins back on, but reported they could not "get it to function the way it should." they further clarified they had a return of symptoms of sometimes when they had the urge to pee, "it just oozed out".Sometimes if they had an urge to pee, they would leak before they were able to make it.They inquired if due to this there was something they needed to do to "reset it." they were on program 1 and before the surgery, they had therapy set at 2.8 volts.The patient initially stated they had noticed since they turned back on therapy the next day following surgery, that therapy was not helping with their symptoms.A therapy and stimulation overview and expectations were reviewed, as well as maximum amplitude.The patient was walked through checking therapy status on the call.They confirmed therapy was on at 3.1 volts on program 1.They mentioned they had changed stimulation to 3.1 volts the other day to see if that would help.They increased stimulation to 4.6 volts on the call and stated they were still not feeling stimulation.They were feeling "maybe a little pressure in that area" (did not clarify area), but stated they were not feeling the normal feeling of stimulation.In the past when they had increased stimulation, they would feel the "vibration" of stimulation, but stated they were not feeling stimulation at all when increasing stimulation.They initially stated all issues noted above started the day after surgery, but stated they felt they were having "some changes" right before their surgery so they thought they needed to make changes to therapy then.They confirmed the month of the start of the event was may.The patient denied any recent trauma or falls, and m entioned therapy was working so well for them before this.They were redirected to their healthcare provider to discuss therapy and symptoms.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the patient.They reported that they had seen their physician's assistant last week and had an appointment to see the nurse and manufacturer representative the day of the report.They planned to call back after the appointment to review and provide responses to the questions from the letter they received regarding their initial report.

Event Description

Additional information was received from the patient who called back reporting a continuation of event reported in this case.The patient stated they had appointments on these dates in 2021: (b)(6), (b)(6), (b)(6), (b)(6), (b)(6) and had the settings adjusted.Pt repeated that they had an unrelated surgery (b)(6) 2021 and following that pt turned ins back on, but it was not helping with symptoms, they were not able to empty their bladder.Pt stated they had a catheter put in for several weeks due to this.Pt stated they the catheter removed and changed pt from program 1 (which pt stated they have always been on, but pt reported they "had no feeling"), so pt changed to program a.Pt stated initially following this they weren't able to urinate enough, but stated late that night when pt got home they were able to urinate and reported it was "somewhat painful".Pt mentioned they were on antibiotics.Pt reported now when pt feels urge to go to the bathroom it's too late and when pt starts walking the urine comes out.Pt also reported still not emptying bladder all the way and pt stated they went to the bathroom 3-4 times last night.Pt stated they have to wear sanitary napkins due to this.Pt initially stated when they turn handset and communicator on they feel vibration of stimulation, but when they put down/turn off devices they no longer feel stimulation.Reviewed therapy and stimulation overview and expectations.Pt stated they increased stimulation from 2.4 to 2.8 and clarified when pt increases/decreases stim pt feels stimulation, but when they stop, they no longer feel stimulation.Pt reported they cannot increase stim any higher than 2.8 because it hurts.Pt stated they have appt.With their doctor on (b)(6).The patient did not know whether the surgery may have affected the device by means of physical force or electromagnetic interference (emi).The issues had not been resolved.

Manufacturer Narrative

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 the patient.They reported that the reason for the call was to get more information on the stimulators.They had a stimulator "implanted in 2008 that's been there for thirteen years," and reported "it was not working," so on friday, their doctor completed surgery to "remove the old implant" and implant a new implant.The battery was only replaced in 2013, and the patient stated the implant was not replaced (evidence reasonably suggested patient was referring to the lead/system by 'implant').They stated "the battery goes out every five years," and they had the battery replaced.Registration information was reviewed that the patient's current implant was implanted in 2019.They stated, "well maybe i have a different one because this one they go to the spine and they put the lead on the spine and the battery in the hip." an overview of the ins was reviewed.The patient reported on friday when their doctor tried to remove their ins, "it broke," and their doctor could not get it out.The reason for the call was to, "find out why the piece [they were] taking off of [the patient's] spine, why did that break?" the role of the help line was reviewed and the patient was redirected to their healthcare provider to discuss and further address the issue.The patient inquired if they could speak with their manufacturer representative about this.The role of the manufacturer representative was reviewed and the patient was redirected to discuss with their healthcare provider.The patient disconnected the call so any further event information was unable to be collected.

Manufacturer Narrative

Continuation of d10: product id: 3889-28, lot# va1v6mq, implanted: (b)(6) 2019, explanted: (b)(6) 2021, 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.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12087486
• MDR Text Key: 266033711
• Report Number: 3004209178-2021-10134
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 65