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

Model Number 97810

Device Problems Therapy Delivered to Incorrect Body Area (1508); Charging Problem (2892)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy.It was reported the patient states that on tuesday they started to feel stimulation/tingling that is going down their leg and they have not made any therapy adjustments since implant.Patient states that whenever they move their leg, they feel stimulation non-stop.This sensation is not comfortable at all, and they want to know what to do for this.Information was reviewed, and caller states that they will decrease stimulation on their own time and if that does not resolve the issue they will consult with their doctor about possible programming changes.Patient also states that yesterday, when they attempted to charge their implant, the recharger would connect then drop the connection, and change to searching for device.Caller states that the device will not charge, and they don¿t know if they are doing something wrong because they did not pair the recharger with the handset like the instructions said.On the call, patient services attempted to troubleshoot the issues (searching for device message was currently on the handset), but the caller states that they would actually like to wait a week to a week and a half longer before they attempt to charge.Caller states that if they run in to issues again, they will call back to troubleshoot.On (b)(6) 2020, the patient calls back stating they are able to start a recharging session but it goes into 'searching' after a couple of seconds.They tried with and without the belt.On the call they rotated the recharger and were able to start an excellent charging session.They stated 10/30 when they were recharging they felt a pulling sensation that felt magnetic.Ps reviewed to follow up with hcp (healthcare professional) if that occurs again.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10823952
• MDR Text Key: 215969177
• Report Number: 3004209178-2020-19766
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/11/2020

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: 09/14/2021
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/11/2020
• Date Device Manufactured: 03/25/2020
• 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: 22 YR