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

Model Number	37612
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Interrogate (1332); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	05/12/2026
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 a patient with a deep brain stimulation implantable neurostimulator (ins) was in the hospital.The patient representative said the ins was unable to charge, the battery level could not be read or checked, and the programmer also appeared to not work.There was concern the therapy was not working and may have been turned off because the patient woke up with a return of baseline parkinson¿s symptoms and unable to move at all.Patient rep described it as if there was no deep brain stimulation and no medication.Phone-based troubleshooting support for the external equipment was offered but declined in favor of in-person troubleshooting support.Additional information received from manufacturing rep.It was determined that dbs was off due to normal battery depletion.Legacy programmer had depleted aaa batteries.Batteries replaced and dbs was able to be programmed on.Impedances normal.Issue resolved.Additional information received from manufacturing representative affirming that hospitalization was due to dbs therapy being off after depleting to 0% due to normal battery depletion with onset symptom may 13th.Rep was able to recharge implant to 50% and turn on therapy.Patient immediately felt significant improvement of parkinson's symptoms and was subsequently discharged.

• 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: 25428012
• Report Number: 3004209178-2026-09623
• Device Sequence Number: 10359227
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: (01)00643169529762(17)181114
• 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: 2018
• 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): 06/08/2026

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: 11/14/2018
• 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: 05/13/2026
• Initial Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 12/14/2017
• 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...."
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male