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

Model Number	37612
Medical Device Problem Codes	Delayed Charge Time (2586); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that normally when pt recharges their implantable neurostimulator (ins), they don't have any issues and they hear the fully charged, tonal sounds within the same amount of time, such as: 30 minutes on the right and 30 minutes on the left and the last time they charged was friday and the dbs therapy app confirmed their inss were both 100 percent but yesterday when they started charging the right side and after about 45 minutes they got the tones confirming they were fully charged but when they charged the left side, after an hour and a half it still did not give the ascending beep so they stopped.Caller asked if they should be alerted that there could be something wrong with the system.Reviewed some recharging information of charge sufficient/ charge complete and recommended keeping an eye on what is going on.Reviewed the option to inform the doctor about variations in the charge duration.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.Called caller back 2 call recordings to review the issue could be caused by positioning and excellent connection vs good con nection can cause variations in how long charging can take, recommended trying to use the recharger app during charging to try to maintain excellent.Offered and emailed recharger handbook.
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 ; 7635265677
• MDR Report Key: 25375735
• Report Number: 3004209178-2026-09435
• Device Sequence Number: 18779473
• Product Code: MHY
• UDI-Device Identifier: 00763000384357
• UDI-Public: (01)00763000384357(17)220314
• 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
• Report Date (Section B): 06/03/2026

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: 03/14/2022
• 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: 05/11/2026
• Initial Report FDA Received Date: 06/03/2026
• Date Device Manufactured: 04/20/2021
• 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: 72 YR
• Patient Sex: Male