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

Model Number	37612
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that having problems with the recharger, said that the paddle started acting up and not responsive.Caller said that they called the local representative, the orange light came on and they did a hard reset.Caller said that the representative did replace the cords for the recharger and they have been able to recharge the implant.Caller said that they like to keep the implanted battery charged at 75%.When asked, caller said that the recharger is in the dock which is plugged in.Caller said that the staff is familiar with the use and care of external equipment.Caller also said that patient saw the nurse practitioner yesterday and everything seemed to be working as expected regrading the implant.When asked, caller said that recharging was not even attempted during the appointment.Caller did say that at the appointment indicated that internal battery is charged to 75%.Then caller said that more recently they noticed that the battery lights are rapidly moving.Recharger not charging.Caller isn't with the patient right now.When asked, caller said that they do use the patient programmer to connect and right now on the middle row is seeing two additional icons, said one looks like a paddle.Caller to call back when they are with patient later today to troubleshoot further.Reviewed replacement time frame and also suggested that if needed, for caller to contact the local representative, to request if they can come and recharge the implant.Also based on age of implant, reviewed eri (elective replacement interval) information for educational purposes only.They send repair request.Patient representative (caller) called back and repeated information previously noted.Caller stated the recharger was still displaying scrolling battery lights and they had tried hard resets already.Agent walked caller through attempting another hard reset of the recharger, but scrolling battery lights persisted.Repair request sent.
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), analysis of wr9200, serial/lot #: (b)(6) found led's scroll continuously device is unresponsive.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 ; 7635265677
• MDR Report Key: 24998809
• Report Number: 3004209178-2026-07212
• Device Sequence Number: 9034101
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: (01)00643169529762(17)171128
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: 11/28/2017
• 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: 04/20/2026
• Initial Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 12/28/2016
• 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: 71 YR
• Patient Sex: Male