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

Model Number 97800

Device Problems Break (1069); Disconnection (1171); Energy Output Problem (1431); Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id 978b128 lot# (b)(6) serial# 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: 20-sep-2024, udi#: (b)(4).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 consumer via a manufacturer¿s representative (rep) regarding a patient who was implanted with an imp lantable neurostimulator (ins) for urinary/bowel disfunction and fecal incontinence.It was reported by the rep that the lead was fractured, damaged, or broken.The lead was fractured just outside the header.Troubleshooting performed included an impedance check that was all abnormal and the system would not let them increase stimulation past 0.4 giving a max stimulation level error.The cause was not known.Device revision was performed/planned for 2024(b)(6) 2024.The patient returned a call from the outbound post-implant program on (b)(6) 2024 and reported that they did not need any further calls as thisimplant was "a redo." the patient further explained that the "first time around" they had the trial and then the permanent implant and that the permanent one broke in their body.The patient denied any falls or traumas that would have led to the event and further clarified their comment on how the permanent one "broke," that they did an x-ray and they saw that the lead was in place however itgot disconnected and that it was something that the manufacturing representative (rep) had known about and that their managing health care provider (hcp) had never seen and according to the patient "the shit hit the fan" and that they didn't know anything more than that other than they had to get a revision last month where they replaced the system.The patient stated they "heard it was a disaster when they took it out." the patient stated "document this if you will but i need to move on" and stated they were working with a medtronic representative (rep) with their new system.The patient stated firmly they wanted to "move on" so patient services did not ask any further questions about the event as the patient did not want to answer any further questions about the old system. additional information was received from a manufacturer representative (rep).The confirmed that the device was explanted as of (b)(6) 2024.

• 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: 18878759
• MDR Text Key: 337367451
• Report Number: 3004209178-2024-06811
• 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: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2024

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: 02/15/2024
• Initial Date FDA Received: 03/11/2024
• Date Device Manufactured: 07/14/2023
• 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 Sex: Female