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

Model Number 3058

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 03/22/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A consumer implanted for gastrointestinal/pelvic floor reported starting about three weeks ago they started to have problems and were having severe pain in the bicycle seat area, but when the device was shut off the pain stopped.No further complications were reported.Additional information was received.It was reported that the circumstances that led to the pain was when the unit was on.The diagnostics and steps taken to resolve the pain included turning the device off for several days and then turning it back on, and various calibrations until it worked better.No further symptoms and complications reported.Additional information was received from a consumer.It was reported that the device was not working for 6 months and had been shut off for a month; it was in their body and not working.The patient started to get shocked in their buttocks area so they shut off the device.A manufacturer representative reprogrammed it and it was working ok for another 2-3 months, and 3 months ago, the patient had the same issue with the shock; they went to a new healthcare provider (hcp), they adjusted it, and it seemed to work for 1 month, so it had been off since then again.The patient was shocked 3 times: in april/may and the third time a week ago.The patient was having the device removed;however, they did not have a date of explant.The implantable neurostimulator (ins) had a lot of problems since placed; it had other problems where it wasn¿t working great so they adjusted it.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the malfunction was in either the unit or the wiring.There were no further symptoms or complications reported or anticipated.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6994903
• MDR Text Key: 90835399
• Report Number: 3004209178-2017-22974
• 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: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

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 Expiration Date: 04/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/01/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 12/01/2017
• Date Device Manufactured: 10/21/2014
• 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 Weight: 87