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

Model Number 97810

Device Problems Failure to Interrogate (1332); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Nausea (1970); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Electric Shock (2554)

Event Date 03/22/2024

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 healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient is currently in the er, and on friday, the patient experienced shocking symptoms along with having to go to the bathroom every 1.5 hours.On friday, the patient tried to turn the ins off, but communication was unsuccessful.Yesterday, the patient started having other neuropathic symptoms, including right leg pain and pain at the bottom of their foot.The caller reported no swelling or erythema.The caller stated today that the patient hasn't been able to urinate at all and is having to try and force urine out, but that they did just urinate a little bit.A bladder scan showed the bladder contained only 7 cc of urine.Tss asked if the patient received shocking when they were recharging the ins, and the patient stated no; it was when they were sitting down on the toilet.Tss walked the caller and patient through connecting to ins with the myther apy app, and it showed a power on reset and therapy was currently off.Battery level showed ins was at 70%.Tss reviewed the meaning of por but found that it was unknown when por occurred.The patient stated they last charged ins about 10 days ago, and they typica lly charge about every 10 days.The patient reported that they had not had any falls.Tss heard the patient mention nausea and headaches in the background, and tss attempted to clarify if that just started with this shocking event, but neither the neither the patient nor the caller responded.The issue was not resolved through troubleshooting.The caller was redirected to nas.Tss offered to walk through the clinician app for further troubleshooting, but the caller declined.

• Brand Name: INTERSTIM
• 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: 18997183
• MDR Text Key: 339134475
• Report Number: 3004209178-2024-07992
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

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: 03/28/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2024
• Initial Date FDA Received: 03/28/2024
• Date Device Manufactured: 09/28/2021
• 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: 57 YR
• Patient Sex: Female