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

Model Number 97800

Device Problems Disconnection (1171); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Insufficient Information (3190)

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

Event Date 04/04/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: 978b128, lot# va2xlxz, 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: 31-oct-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

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the or case today went fine.Impedance check was good, lead placement was good and motor response was good at low levels.2.In post op, patient is not feeling any stim.Patient able to increase stim on all programs.Patient checked impedances - all green - no values available at the time of the call.Reviewed checking values for impedances and change programming if needed.Caller reported there will be an x-ray to check lead placement.Additional information was received from the patient.The reason for call was patient said the procedure was not successful.Patient said the wire moved from the time they were taken off the table and transferred to the bed and the device disconnected.Patient mentioned that the procedure was reschedule for tomorrow (b)(6) 2024 but they are not sure that they can make it because they need to look for transportation in a short notice.The patient was redirected to their healthcare provider to further address the issue.

Manufacturer Narrative

Continuation of d10: product id (b)(4) lot# va2xlxz serial# implanted: (b)(6) 2024.Explanted: 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 lead migrated out of the foreman to the posterior side which was verified by x-ray.The issue was reported as being resolved as the lead was removed and replaced on (b)(6) 2024.Additional information was received from the patient.The patient repeated information regarding lead migration and unsuccessful implant procedure.Patient stated the second procedure was successful and everything is going good.

• 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: 19078809
• MDR Text Key: 339813109
• Report Number: 3004209178-2024-08796
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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: 04/09/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 05/01/2024
• 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: 78 YR
• Patient Sex: Female