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

Model Number 3058

Device Problems Overheating of Device (1437); Unauthorized Access to Computer System (3025)

Patient Problems Burn(s) (1757); Pain (1994); Burning Sensation (2146); Insufficient Information (4580)

Event Date 02/28/2021

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor therapy and urinary dysfunction/sacral nerve stim.It was reported that the patient was calling from germany while they were visiting their mother, however the patient was a us citizen whom was implanted in colorado.The patient called to receive replacement external devices due to their devices being stolen.The patient stated that one of their devices was stolen in north carolina, and they think the other was taken out of their purse in baltimore.The patient also reported that they believe they are being hacked intermittently, and that such hacking is causing a burning of the nerves near the implant sight and down the legs.The patient also told the agent that their pain receptors are being blocked due to the device being hacked and they removed their dress and saw a burn, but did not feel the burn occur.The patient reported they called manufacturing representative (rep) and notified them of the hacking issue and pain in early (b)(6) 2021.The caller noted that the rep checked the device and it did not show anything.Agent asked the patient when the issue started, when the rep was notified, and verified the patient's hcp.Troubleshooting was not attempted.The caller was redirected to sunmed.Throughout the call, the caller seemed to be confused and was difficult to understand.

• 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: 19082171
• MDR Text Key: 340576438
• Report Number: 3004209178-2024-08839
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2024

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: 05/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/10/2024
• Date Device Manufactured: 11/17/2020
• 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: 47 YR
• Patient Sex: Female