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

Model Number 3058

Device Problems Environmental Compatibility Problem (2929); Insufficient Information (3190)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

Date is estimated; year is 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 fecal incontinence and gastrointestinal/ pelvic floor.It was reported that on (b)(6), the patient was involved in a "bad car wreck," where their back almost broke in two.They had had surgeries due to this, and reported either, "something i have done or the surgeries or something has messed up my thing that was put in." the patient clarified they were referring to their ins.They thought the ins was intended to help both their bowel and bladder.Their side where the implant was located hurt really badly and there was a "big bulge" in the center of their back.The role of the manufacturer help line was reviewed and the patient was redirected to their hcp to discuss this issue.They requested physician listings to locate a doctor to manage their device.When asked for the event date, the patient stated their accident was on (b)(6) 2021.They had surgery on (b)(6), and shortly after the pain went away following surgery, was when they noticed the issues started.The patient was redirected to their healthcare provider to further address the issue.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12078916
• MDR Text Key: 265985723
• Report Number: 3004209178-2021-10068
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• Date Device Manufactured: 06/09/2016
• 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 Age: 70 YR