MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number	37603
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: 3708660, serial# (b)(6), implanted: (b)(6) 2016, explanted: (b)(6) 2024, product type: extension.Section d information references the main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(6), ubd: 28-jul-2020, 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 or Problem Description
It was reported by the manufacturer representative (rep) that the patient's extension was severed at the connection point between the extension wire and the ins adaptor.The patient presented with the left battery stimulation off due to its ineffectiveness.The pa tient suspected it was due to "compatibility issues" with having a mixed system.During the operation, it was discovered that the extension wire had completely severed from the battery at the point of the boston scientific adaptor.The cause was unknown.The patient didn't recall a single event in which the break occurred.The extension was replaced on (b)(6) 2024.The impedances were normal with the new extension wire, indicating no issues with the lead.The problem was resolved by the time of this report.The patient was alive with no injuries.See (b)(4) for bsc ins off due to 'ineffectiveness.' additional information was received from the manufacturer representative (rep) on 2024 jul-22 confirming the patient was in surgery for normal battery replacement.The left chest boston scientific battery (unknown model and sn) was turned off at the time of the patient's arrival at the hospital for a return to a fully mdt system due to the release of the percept rc and the ineffectiveness of the bsc batteries.

• Brand Name: ACTIVA
• Common Device Name: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19903560
• Report Number: 2182207-2024-03378
• Device Sequence Number: 6557216
• Product Code: MRU
• UDI-Device Identifier: 00763000100353
• UDI-Public: 00763000100353
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/05/2024
• Date Device Manufactured: 05/08/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female