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 Code	Ambulation or Postural Difficulties (2544)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the caller said the patient (pt) had their right battery replaced in april and at that time the left battery was at 100%.Caller said 3 weeks ago the battery dropped to 75% and the next week it dropped to 50% then in a few days it dropped to 0.Caller saw an eos message on the pt programmer.Caller said the healthcare provider (hcp) told them it was very unusual for the ins battery to deplete this fast.Pss reviewed the implantable neurostimulator (ins) battery level doesn't show a percentage that it shows ok or low and a voltage.Patient services (pss) asked if they could have been looking at the patient programmer battery level.Caller communicated w/ the ins and saw an eos message which they were not able to bypass.Caller said the pt is completely immobile because the ins is depleted.Caller got a call from a nurse and had to end the call.
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 ; +1(763)526-5677
• MDR Report Key: 50308454
• Report Number: 3004209178-2026-13930
• Device Sequence Number: 13436949
• Product Code: MHY
• UDI-Device Identifier: 00763000519223
• UDI-Public: (01)00763000519223(17)240228
• 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: 2023
• 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): 08/18/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2024
• 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: 08/14/2026
• Initial Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 09/13/2022
• 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: 71 YR
• Patient Sex: Female