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

Model Number 3058

Device Problems Energy Output Problem (1431); Environmental Compatibility Problem (2929)

Patient Problem Urinary Incontinence (4572)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date is estimated; month and year are valid.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 urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that they didn't know if the device was working anymore.Patient further clarified that they received a letter from [manufacturer] talking about the battery approaching 5 years of life and to have it checked and the patient stated they had an appointment planned with their managing health care provider (hcp) on (b)(6) 2024 to do so however they were concerned it wasn't working as well anymore since a bad accident they had in (b)(6) 2023.The patient stated they got hit pretty hard in their insides and their hip was broken and that they'd just gotten through 74 days of physical therapy/rehabilitation from the accident.The patient stated they lost control of their bladder after the accident which the doctor told them that was a common occurrence after an accident but the patient stated they thought the therapeutic effect had been diminished since the accident.The patient's reason for call had been they went to the clinic with the letter they'd received from [manufacturer] and the nurse there told the patient to call patient services about scheduling a manufacturer representative (rep) to be at their april 16th appointment.Patient services reviewed the role of the rep and provided the patient with the national answering services (nas) number to provide to the hcp to page a rep for their appointment.The patient was going to provide the hcp with the nas number to page a rep to their appointment and follow up with their hcp about their device concerns at their appointment on (b)(6) 2024.

• 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: 18970528
• MDR Text Key: 338685630
• Report Number: 3004209178-2024-07748
• 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: 03/25/2024

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: 04/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/25/2024
• Date Device Manufactured: 11/05/2018
• 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: 73 YR
• Patient Sex: Male