MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number	37612
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Battery Problem (2885); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that recharger has died and does not make any noise.When they put it on the charging dock the battery light scrolls rapidly.Patient reported they had emailed rep yesterday about this and attempted a hard reset but this did not resolve the scrolling battery light.Patient also noted that they have to hold the cord at an angle in the dock to get it to work. the charging port is loose. patient was not certain if the micro usb dock cable was the issue or the port on the dock.The recharger is not holding a charge and not charging their implanted device".Agent had them plug the recharging dock on the wall, and had the wireless recharger sit on it.Caller stated that when they hold the dock upright, the scrolling green battery light comes up on the recharger, but there are no lights when it's flat.Agent had them reset the recharger but it stayed unresponsive out off the dock, and with a scrolling green light when on the dock.Caller also stated that when they move the dock around, the charger port seemed a little loose, the green light on the dock goes out whenever it's moved when sitting on the floor, and it only goes on when the dock is sitting upright.Agent requested a replacement wireless recharger, dock,and charging cord through repair.Agent documented reported event.
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id: (b)(4), serial/lot #: (b)(6), ubd: , udi#: h3: analysis of the wireless recharger wr9200 (serial #:(b)(6)) revealed that the recharger was unresponsive.The led's scroll c ontinuously 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: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 50269918
• Report Number: 3004209178-2026-13740
• Device Sequence Number: 18706055
• Product Code: MRU
• UDI-Device Identifier: 00763000100360
• UDI-Public: (01)00763000100360(17)201214
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• 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
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: 12/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2020
• 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: 21 YR
• Patient Sex: Female