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

Model Number 3058

Device Problems Failure to Interrogate (1332); Pocket Stimulation (1463); Communication or Transmission Problem (2896)

Patient Problems Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2024

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, urinary dysfunction/sacral nerve stim.It was reported that last time successfully connected to implant was about 5 months ago.When asked, patient said that the setting was set at 0.4.Patient said that this time when tried to connect, earlier received no device found.Reviewed general use of handset and communicator and patient was attempted to connect however was not successful however said that as soon as placed the communicator over the implant felt strong stimulation/buzzing at neurostimulator site and then after a few seconds this subsided.Patient repositioned communicator several times and still unable to connect however with each attempt reports felt stimulation at neurostimulator site and now also in vaginal area.With instruction, patient turned off the handset and powered off the communicator.The issue was not resolved through troubleshooting.Patient said their healthcare provider in california is going to call in about ten minutes.Asked, if arrangements can be made to have another person with patient so that other person can hold and reposition the communicator.Patient said yes, that someone will be available in about thirty minutes.Patient said will be calling back later.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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19154342
• MDR Text Key: 341303297
• Report Number: 3004209178-2024-09522
• 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: 04/22/2024

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: 08/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 02/24/2021
• 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: 76 YR
• Patient Sex: Female