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

Model Number 97810

Device Problems Energy Output Problem (1431); Malposition of Device (2616)

Patient Problems Diarrhea (1811); Incontinence (1928); Device Overstimulation of Tissue (1991); Twitching (2172)

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the patient noted having difficulty charging the ins.The recharger will connect to the stimulator and start charging and then it disconnects.The issue started a week ago today (friday).Patient had 0% charge yesterday and had a few accidents when working.Patient had been preparing for a colonoscopy he had on wednesday, had more water coming out that end then then the other end.The following troubleshooting steps were performed: reset the recharger, recommended patient lean forward while sitting to optimize ins position, repositioned the recharger, located the ins by looking for incision and/or palpating the ins, dismissed code 3167.Additional troubleshooting information; agent asked if patient turned off the stimulator for the colonoscopy they said they didn't bother recharging it.Patient said their colonoscopy was normal.They did not remove any polyps.Patient can't really feel the stimulator.Patient moves the stimulator around until they find a good connection.Usually they just sleep on it or prop it up on pillows.Patient said they had an error with the bluetooth but they corrected that.Patient got the stimulator charged to a 100% on the call.Patient said, on some programs, the stimulation is so intense their leg will start twitching.Agent exp lained to patient that if that happens they have the stimulation too high and they should back it off.Patient increased the stimulation and is going to monitor their symptoms to see if they improve.Additional information was received from the patient.They reported that the cause of the stim on some programs being so intense their leg will start twitching was determined.The patient did not indicate a likely cause but noted the steps taken as "first no signal received, disconnected, wife rebooted and re-entered.Wife changed program and frequency, tolerating well." patient added an "addendum" at the top of the letter indicating the following: "called 1/19/23 regarding device function during an mri and pet ct scan scheduled later this month for prostate.Medtronic customer service rep called them and provided instructions before each diagnostic procedure.".

• 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: 18231945
• MDR Text Key: 330558935
• Report Number: 3004209178-2023-24409
• 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: 11/29/2023

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: 04/28/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 11/29/2023
• Date Device Manufactured: 10/29/2021
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 93 KG