MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	37612
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient (pt) is having trouble with their communicator since yesterday.Patient stated their implant is off and they want to turn it back on but their communicator will not turn on.Patient confirmed on the call the communicator powered on.Agent walked patient through steps to connect with their implant.Patient initially got no device response when trying to connect with their implanted neurostimulator.Patient repositioned communicator on their implant and confirmed successfully connected with their implant.Patient stated therapy was off.Patient then stated they saw no device response again when trying to turn therapy on.Agent reviewed to ensure communicator was still over patient's implant.Patient confirmed communicator was on their implant and confirmed successfully turned therapy on.Patient reported once turned therapy on that their voice was "different" and stated their voice is different for a few seconds with turning therapy on.Patient stated it felt like a "rush" (agent unable to make out what else patient said at this point in the call).Patient later confirmed they were feeling better during the call following turning therapy on.Patient confirmed therapy was on and implant battery was at 100%.Patient mentioned they are having mri tomorrow.Agent reviewed how to turn therapy on/off for mri per patient's request.The troubleshooting steps that were taken on the call resolved the issue.Agent had a difficult time hearing patient throughout call and made best attempt to collect all relevant event information.
Additional Manufacturer Narrative
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: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 25694819
• Report Number: 3004209178-2026-11169
• Device Sequence Number: 9875602
• Product Code: PJS
• UDI-Device Identifier: 00763000519247
• UDI-Public: (01)00763000519247(17)230114
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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: 01/14/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 07/02/2026
• Date Device Manufactured: 02/18/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Male