MAUDE Adverse Event Report: MPRI TBD; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	3708140
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a manufacturer representative regarding a trial patient who was using an external neurostimulator (ens).The reason for the call was the caller stated they were in a case for a buried lead trial using 37081 extensions.The caller stated that the hcp attempted to use the connector boot but had a hard time putting it on and felt that it was "stretching the extension".Therefore, the hcp elected to not use the boot, and the caller inquired about irrigating the connection.Troubleshooting was not required.The troubleshooting steps that were taken on the call resolved the issue.The technical services specialist (tss) reviewed information for the manual about placing the boot and irrigation.Tss reviewed that without the boot, the connection may be more likely to have fluid ingress, but it is the hcp's decision around irrigating the connection.No symptoms were reported.
Additional Manufacturer Narrative
Continuation of d10: product id 97725, serial# unknown, product type external neurostimulator.Section d information references the main component of the system.Other relevant device(s) are: product id: 97725, serial/lot #: unknown, 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received from manufacturer representative (rep) who provided patient info and device serial numbers.Rep reports issue was resolved.
Additional Manufacturer Narrative
Continuation of d10: product id 9772501, lot# nlj715685n, implanted: (b)(6) 2024, product type external neurostimulator.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: TBD
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba,pr MN 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba,pr MN 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21056778
• Report Number: 2182207-2025-00007
• Device Sequence Number: 8656777
• Product Code: LGW
• UDI-Device Identifier: 00643169887749
• UDI-Public: 00643169887749
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3708140
• Device Catalogue Number: 3708140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/11/2025
• Date Device Manufactured: 08/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 81 YR
• Patient Sex: Male