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

Model Number	37612
Medical Device Problem Codes	Charging Problem (2892); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient with a deep brain stimulation implantable pulse generator (ipg) contacted support because the patient programmer was not connecting to the stimulator and the patient described breathing difficulty that was worst on the day of the call.The issue reportedly began several days earlier.The patient programmer displayed a warning that its batteries were low and needed to be changed, and after the patient replaced the batteries, the programmer connected to the stimulator and indicated the stimulator battery charge level was low.The patient also reported that therapy was off.The patient attempted to use a wireless recharger and handset to charge the stimulator, and the recharging application would not connect to the recharger, displaying ¿not found.¿ multiple recharger resets were performed by holding the power button for 45 seconds, and repeated manual entry and scanning attempts of the recharger serial number were performed before the recharging application connected.Once connected, the recharging application displayed ¿my battery 0%,¿ ¿my therapy off,¿ and ¿excellent connection,¿ and charging was initiated.No symptoms were reported.2026-aug-04 rtg1081981 sap ecc service & repair (b)(4) (con): additional information has been received that same issue with the wireless recharger not being able to stay connected with the implant for long even when it was right over the implant site.The patient said the issue has gotten worse to where the wireless recharger will just beep and beep.The patient said there had been no changes in their implant site.Agent reviewed information about activa rc implant longevity with patient.Agent emailed repair to send replacement wireless recharger.Agent reviewed that if they have the same issue with the new wireless recharger patient would need to follow up with the health care provider.Additional info received from patient that they received a replacement wr but they continued to experience poor coupling.The patient was redirected to their hcp to further address the issue.The patient mentioned that they have a neurologist, but they weren't sure if the neurologist was familiar with dbs.Agent re-opened the case and emailed physician listings to the patient.
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: 50767747
• Report Number: 3004209178-2026-15559
• Device Sequence Number: 9488764
• Product Code: MHY
• UDI-Device Identifier: 00763000384357
• UDI-Public: (01)00763000384357(17)220714
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: 37612
• Device Catalogue Number: 37612
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 08/18/2021
• 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...."
• Patient Age: 76 YR
• Patient Sex: Male