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

Model Number	37612
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Battery Problem (2885); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when they pulled the recharger out and put it on the dock, prior to starting a charging session with the implant, the green lights started scrolling rapidly.Off the dock, they said it was dead. recharger is unresponsive on the dock. caller said patient hadn't charged the implant in two weeks so they were hoping to get the patient charged up as soon as possible.Caller said they called they'd looked online for troubleshooting and called the manufacturer company representative this morning however both resources told them to call patient services (ps).Ps had the caller check the status of the dock and the caller confirmed that the green light was solid when the cable was plugged in and that the light would not flicker if they moved the dock around.Patient services had the patient place the recharger on the dock and hold the power button down for ten seconds but that did not resolve.Caller took recharger off the dock and ps had the caller do a recharger reset, however the issue was not resolved through troubleshooting.Recharger maintenance considerations were reviewed with the caller and the caller said they hadn't realized they needed to always have the recharger on the dock an charging when not in use but said they would do so from now on.A request was sent to the repair department to replace the recharger.
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id: wr9200, serial/lot #: (b)(6), ubd: , udi#: h3: analysis of the wireless recharger wr9200 (serial #:(b)(6) revealed that recharger is locked no download available.The led's scroll continuously and the flash sector read/write protection bits have become set.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: 50865555
• Report Number: 3004209178-2026-16089
• Device Sequence Number: 21498052
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• Combination Product (Y/N): N
• 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
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 05/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0294-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Patient Age: 70 YR
• Patient Sex: Male