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

Model Number	37602
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	Fall (1848); Ambulation or Postural Difficulties (2544)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.Continuation of d10: product id: 37602 ((b)(6)); product type: 0197-implantable neurostimulator; implant date: (b)(6) 2021; explant date.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the patient is looking for a new hcp that can help with the device, it is not working and patient can no longer move, because his stimulator's battery already worn down.They clarified and reported that the patient's batteries went out about a week or two ago and now the patient is falling all over the place and can't get up unless they are with the caller.The caller indicates that the healthcare provider the patient has been seeing in idaho falls does not know anything about dbs or parkinson's.They were directed to another hcp, but they cannot get in until january.
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
Additional information was provided by the patient, indicating that the battery was a five (5) years old device that and went out due to normal battery depletion.The replacement date was (b)(6) 2025.The issue was resolved.

• 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: 23464770
• Report Number: 3004209178-2025-18773
• Device Sequence Number: 8879708
• Product Code: MHY
• UDI-Device Identifier: 00763000384333
• UDI-Public: (01)00763000384333(17)220528
• 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,Followup
• Report Date (Section B): 01/09/2026

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: 05/28/2022
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/09/2026
• Date Device Manufactured: 12/07/2020
• 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
• Patient Age: 66 YR
• Patient Sex: Male