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); Charging Problem (2892)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
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 had been unable to charge the implant since (b)(6), the previous week, and presented for evaluation.At that time, the device was found to be turned off despite a reported battery level of 25%.The caller said the patient required emergency room evaluation over the weekend due to the inability to move.It was noted that the patient had contacted a manufacturer representative regarding the replacement of the recharger.Still, it was advised that a new device could not be issued until the required documentation was completed, which had not yet been received.Patient services confirmed during the call that the patient had the appropriate equipment for charging the implant, and during troubleshooting, the caller connected to the implant and verified that charging was occurring.The healthcare professional reactivated therapy and confirmed that the battery had depleted on the (b)(6), which resulted in therapy being turned off.The issue was resolved following troubleshooting, and the patient was redirected to the healthcare provider for further evaluation.Additional information received from patient representative indicating that now the implant was 100% charged.The patient provided additional information, confirming previously reported information that the hcp was able to turn their therapy back on, but was wondering about the chances of it happening again and the possible cause of the therapy turning off.Patient services reviewed battery longevity and that the battery got depleted resulting to the therapy turning off on its own.Patient then stated that the therapy kept easing down, from 75% to 25% and then to 0%, but it's okay now.The patient also mentioned that they never got any training to make it work.
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 received from patient.Patient said they can't get the ins to charge past 75%.Reviewed how to use the recharger application.Patient started a charging session and the ins went from 75% to 100% during the call.

• 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: 24853629
• Report Number: 3004209178-2026-06317
• Device Sequence Number: 10476264
• Product Code: MHY
• UDI-Device Identifier: 00763000519247
• UDI-Public: (01)00763000519247(17)230914
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 09/14/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 10/20/2022
• 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: 74 YR
• Patient Sex: Female