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

Model Number	37601
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyskinesia (2363); Ambulation or Postural Difficulties (2544); Cognitive Changes (2551); Insufficient Information (4580)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an allied healthcare provider and patient representative that the patient was currently hospitalized due to an abrupt return of uncontrollable dyskinesia for the past several days.It was reported that similar symptoms had occurred in the past when deep brain stimulation was turned off and recalibrated, and that the device had not been checked since 2020.The patient was unable to eat, hold a drink, and slid off a couch because of the dyskinesia.The patient rep described the patient as flopping all over without ceasing.Computed tomography (ct) scans were performed and nothing was reported to be observed in respect to the deep brain system.Infection was ruled out.The patient representative was unsure if the implantable neurostimulator and/or programmer was functional.Additionally, patient representative reported that patient was experiencing hallucinations and mental status, but were unsure if was related to the deep brain stimulation (dbs) therapy/device or related to a known prostate issue that was described as pre-existing.The patient representative reported that patient had a history of bladder retention with last event taking place about a year earlier.Troubleshooting could not be performed because no patient programmer was available.Next steps was to request field support to interrogate device per healthcare provider (hcp) request.
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: 25271554
• Report Number: 3004209178-2026-08864
• Device Sequence Number: 13201197
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: (01)00763000175719(17)201114
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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: 11/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/25/2026
• Date Device Manufactured: 05/23/2019
• 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: 65 YR
• Patient Sex: Male