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

Model Number 97800

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395)

Patient Problem Incontinence (1928)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id 978b128 lot# va2tdel; 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: 09-apr-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.

Event Description

2024-mar-12 mpxr 1159471 (con): information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction.It was reported that the patient's lead migrated or dislodged.The patient had a loss of stimulation and aloss of therapy and was experiencing a return of baseline symptoms (urge incontinence). patient did not have sensation at time of office post op call on thursday 2024-mar-07.The manufacturer representative (rep) was contacted on monday to troubleshoot with patient; patient did not experience any sensation at time of troubleshooting. office notified of situation, healthcare provider (hcp) ordered x-ray imaging on tuesday 2024-mar-12 and x-ray showed lead had completely dislodged.Lead revision was scheduled for 2024-mar-13 and the rep will follow up with any updates and additional information.

Event Description

Additional information was received from the manufacturer representative (rep).It was reported that the cause of the lead dislodgement was unknown.The lead was completely out of the foramen, impedance was normal at time of original implant and images were taken at the time of implant for confirmation.When asked the most likely cause the rep reported that patient is morbidly obese.

Manufacturer Narrative

Continuation of d10: product id: 978b128, lot#: va2tdel, 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.

• 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: 19013949
• MDR Text Key: 339044845
• Report Number: 3004209178-2024-08222
• 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: 04/24/2024

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: 03/12/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/24/2024
• Date Device Manufactured: 07/03/2023
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 181 KG