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

Model Number	37612
Medical Device Problem Codes	Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 37751 serial# (b)(6) product type recharger product id 37761 serial# (b)(6) product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 37761, serial/lot #: (b)(6).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 information was received from a patient regarding an external device.The reason for call was the patient reported that maybe a week ago or so ago, they noticed the connector pin on the desktop charger was broken and that when they plugged it into the recharger last night ((b)(6) 2026), the port on the recharger cracked and wouldn't hold the cord in place to charge the recharger anymore.The patient stated they looked at it under a microscope and the pins were broken.Patient services reviewed with the patient that the 37751 was no longer being manufactured and that they would have to transition to the wireless recharging system and advised the patient they would reach out to the field about the issue to start the replacement process.Patient services reviewed that a representative would have deliver the wireless system to the patient and show them how to use it.An email was sent to the field to notify them of the situation.Patient stated their implanted neurostimulator battery was expected to last maybe 3-4 days.Patient services called first rep and left a message and was able to call the other rep and contacted them.They agreed to receive the shipment.Patient services sent requests to repair to send the rep the wireless recharger kit and drape.Rep to contact patient to arrange the training and exchange of external devices.

• 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: 25482492
• Report Number: 3004209178-2026-09922
• Device Sequence Number: 10520983
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: (01)00643169529762(17)160628
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: 06/28/2016
• 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: 06/11/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 08/13/2015
• 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: 73 YR
• Patient Sex: Male