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

Model Number 97810

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Chest Pain (1776); Incontinence (1928); Muscular Rigidity (1968); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 01/16/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor and fecal incontinence.It was reported that when had an accident (was leaking) last night, experienced a shock in vaginal area.Patient confirmed that the shocking sensation had stopped.Patient said that had another accident this morning and also felt so tight, could barely walk.Patient wanted to check charge level using recharger, said it wasn't beeping.Patient said they recharge implant every wednesday.Patient services suggested patient use the communicator to check therapy status and battery level however patient said their husband usually helped and they weren't available right now on another phone call.With instruction, patient attempted to connect however said that it was too challenging and will call back when husband was available.The issue was not resolved through troubleshooting.The caller was redirected to call patient services when their husband was available to resume troubleshooting, explained will check implant and recharger.The patient (pt) called back and repeated the shocking and tightness in their chest sensations and stated they wanted to check the battery level.Pt also mentioned the recharger wasn't beeping to let them know the ins was low.Pt services walked pt through device function and smart programmer general use.Pt checked battery levels of ins, handset and communicator and all have charge.Pt also turned on recharger and recharger was functioning as intended.Pt seemed to be confused on what was contributing to the shocking and tightness.Pt services recommended pt follow up with doctor to have system checked.Pt services also offered to show how to turn stimulation off until system can be checked, but pt declined.

Manufacturer Narrative

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.

• 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: 16204320
• MDR Text Key: 309033486
• Report Number: 3004209178-2023-00811
• 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: P080025
• 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: 01/19/2023

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: 07/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 01/19/2023
• Date Device Manufactured: 02/10/2021
• 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: 63 YR
• Patient Sex: Female