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

Model Number 3058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor therapy.It was reported that it doesn't help anymore for the urine.The therapy helped the urine in the beginning.The patient said it stopped helping for the urine in the second year 2017.Patient said it doesn't work as well for the bowel, and that started about two years ago.The patient has had back pain for the last 2 years on the right side which is the side the stimulator is on.They were calling because they wanted to know if they could have the stimulator moved to the left side.Patient hasn't seen their managing doctor since shortly after it was implanted in 2015.They said they can feel a wire or something poking them.Then they said it is more like something is protruding for the last four months.They have had an epidural every 3 months for the last 2 years.They were on no pain medication at all.Their pain level is a 7 for at least the last 2 and half years.The last epidural they had on (b)(6) 2020 didn't work at all and it usually lasts two months.The patient knows it is working because she can feel the stim.They said they can feel the smallest pulsation.The patient thinks they were around 1.3 volts currently.The patient said if they have a massage, they tell them to stay away from the stimulator because it hurts if you rub over it.The patient was redirected to their healthcare provider to further address the issue and see about moving the stimulator to the opposite side.The patient's relevant medical history included she said she has had surgeries for her bladder and they still had mesh.Patient called back and reiterated previous reported event: that they had pain with their previous system that began probably in 2017 but they didn't know it was from the ins on the right side.They stated doctors had them trying pills for restless leg syndrome and that they "tried all these different things" and had 15 epidurals and they still had pain.Patient stated not one person thought it was the implant until the patient suggested it.Patient stated they followed up with their current managing health care provider (hcp) on record and told them they wanted to switch the ins from the right side to the left side and the hcp said "ok let's do that".Patient stated almost immediately upon getting the replacement ins on the left side instead of the right side, the pain was gone.Like 2 weeks went by and the pain was no more.

Manufacturer Narrative

Continuation of d10: product id 3889-28 lot# (b)(6) implanted: (b)(6) 2015 product type lead medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19184889
• MDR Text Key: 341077008
• Report Number: 3004209178-2024-09789
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2024

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 Expiration Date: 11/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/25/2024
• Date Device Manufactured: 06/10/2015
• 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
• Patient Sex: Female