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

Model Number 3058

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Micturition Urgency (1871); Pain (1994); Chills (2191); Electric Shock (2554); Insufficient Information (4580)

Event Date 03/22/2024

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'd been having some issues with chills and pains in the lower abdominal area.The patient stated they'd seen their primary care physician twice and that they'd ruled out a urinary tract infection or anything wrong with their bowels.The patient stated they called their urogynecologist's office and they told the patient to call manufacturer to see if something might be going on with their ins.The caller stated last night it getting worse so they turned the therapy off, and the only difference it made was that they felt like they had to go to the bathroom all the time and they stopped getting the sensation like an electrical shock going through your body.Patient clarified when they had the urge to go to the bathroom they would get an electrical shock through their lower half and that sensation stopped with the therapy turned off but not the chills or abdominal pain.Patient services asked the patient if they had had any falls or traumas and the patient stated "no." patient services asked the patient if they'd done any scans of their abdomen and the patient stated they only did an x ray of the bowels today and they didn't look at their stomach.Patient service reviewed the role of patient services with the patient and redirected the patient to their health care provider (hcp) to seek help for their issue, reviewing with the patient that the health care provider (hcp) could always page a manufacturer representative to come to the office to check the implanted system.Patient services also provided the patient with the nas phone number for their healthcare provider to use if they wanted to page a representative to come and take a look at the patient's system.

• 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: 19020905
• MDR Text Key: 339246180
• Report Number: 3004209178-2024-08283
• 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: 04/02/2024

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: 09/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/02/2024
• Date Device Manufactured: 03/16/2018
• 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: 46 YR
• Patient Sex: Female