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

Model Number 97800

Device Problems Break (1069); High impedance (1291); Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  Injury  

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction.It was reported that the patient was scheduled and insured for a lead revision.As they opened the pocket that was when the doctor noticed the lead wire was twisted and dislodged from the battery which was causing high impedance over 4000 ohms.The decision was made to place a new generator since the leads were broken off into the battery casing.The patient was not prepared to pay for a new generator as it was required to get their therapy working properly again.

Manufacturer Narrative

Continuation of d10: product id 978b128 lot# va2r4nw; implanted: (b)(6) 2023; explanted: (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: 24-jul-2024, 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

H3 product analysis 97800: the implantable neurostimulator (ins) passed functional testing; however a lead or lead parts were observed inside the implantable neurostimulator (ins) connector port.Product analysis 978b128: analysis identified that the outer insulation of the lead was twisted.Analysis identified that the 0 conductor was broken at the proximal end of the lead as the result of factors beyond intended reliability.Analysis identified a break in the insulation under the 0 connector at the proximal end of the lead.Continuation of d10: product id 978b128 lot# (b)(6) serial# implanted: (b)(6) 2023 explanted: (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: 19102850
• MDR Text Key: 340107212
• Report Number: 3004209178-2024-09051
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/14/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2023
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female