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 Codes	Muscular Rigidity (1968); Ambulation or Postural Difficulties (2544)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient was in the hospital for 4 days after being in the er.Caller said the implantable neurostimulator (ins) shut off inadvertently which caused the emergency.Caller said the patient is usually mobile.Caller said the patient had a sudden rapid drop and within 24 hours he was bedridden.Caller said they discovered the ins was off and when the patient turned back on his motor function came back.Caller said the ins never depleted and remained at 75%.Caller said the ins shut off sometime between (b)(6) 2025 and this past weekend.Caller said in (b)(6) or (b)(6) of 2025 the patient started complaining of a pulling sensation in his face but caller said it was not visible to her.Caller said at 1st they said it was dystonia but the patient said it was different from dystonia.Caller said the patient a ct scan and their brain imaged.Caller said when the patient turned stim back on when they were in hospital the pulling got worse and it was visible to the caller, caller said it looked like someone had a hook in the side of the patient's mouth and was pulling on the hook.Caller said they have an appointment w/ healthcare provider (hcp) coming up.

• 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: 24611475
• Report Number: 3004209178-2026-04699
• Device Sequence Number: 13296446
• Product Code: MHY
• UDI-Device Identifier: 00763000384357
• UDI-Public: (01)00763000384357(17)220628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: 06/28/2022
• 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: 03/13/2026
• Initial Report FDA Received Date: 03/16/2026
• Date Device Manufactured: 07/28/2021
• 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: Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male