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

Model Number 97800

Device Problems Energy Output Problem (1431); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Burn(s) (1757); Pain (1994); Discomfort (2330); Electric Shock (2554)

Event Date 04/03/2024

Event Type  Injury  

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction (incontinence, urgency, and/or frequency).It was reported that the patient experienced shock from the device.They felt shocked, like they were burning near vagina.The patient also reported pain, discomfort, soreness, pinching, ache, and pressure.As for troubleshooting, the patient turned down and changed programs.System turned off.Patient reported feeling a ¿pop¿ sensation near the stimulator that occurred 4/3.Ever since then, stimulation has felt different and that when burning started.I still had pain throughout the weekend while ins was off.4/8 patient saw their health care professional on 4/9 and reported symptoms that were not as severe.They are sending patient for x-rays, kept off and will revisit them in 1 week.

Manufacturer Narrative

Continuation of d10: product id 978b128 lot# (b)(6) implanted: (b)(6) 2024 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(6), ubd: 11-sep-2025, udi#: (b)(4).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.

Manufacturer Narrative

Concomitant product id 978b128 lot# va2xjrm, implanted: (b)(6) 2024.Product type lead 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

Additional information was received from a manufacturer representative (rep).The rep reported that the cause of the burning sensation was not determined.The likely cause was noted as being "accute post op pain".It was also noted the x-ray results were normal and the steps taken to resolve the issue were "had a 2nd follow up with physician on (b)(6) 2024.Patient reported that pain is gone." the issue has been resolved.

• Brand Name: INTERSTIM X
• 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: 19181599
• MDR Text Key: 341043562
• Report Number: 3004209178-2024-09737
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• 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,Followup
• Report Date: 05/13/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/13/2024
• Date Device Manufactured: 02/08/2024
• 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 Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female