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

Model Number	37612
Medical Device Problem Codes	Failure to Deliver Energy (1211); Energy Output Problem (1431); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Cognitive Changes (2551); Insufficient Information (4580)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient has not been able to charge their implant for "a month and a half" and believes the implant is in overdischarge mode.Representative stated they are meeting with the patient and the patient's grandson will be coming to the hospital in 30-45 minutes to help troubleshoot the recharger with the external devices.Agent reviewed overdischarge mode and rep plans to call back if needed.Rep states this started a month and a half ago.Rep called back stating they are trying to get the patient to recharge again, but they are super unfamiliar with the recharger kit.Reviewed with the caller how to do a physician mode recharge using the recharger.Technical services reviewed to let the 60 min timer run down and try normal charging session.Reviewed once implantable neurostimulator (ins) is charged up to approx.50%, they will need to interrogate ins with clinician programmer app and clear the por (power on reset) message.A couple minutes into it, rep confirmed that por screen was along with normal charging screen.The troubleshooting steps that were taken on the call resolved the issue." additional information was received from manufacturer representative (rep).Rep reported the cause of the difficulty charging implant was a decline in the patient¿s cognitive status.Rep reported troubleshooting included provided training and education to the patient and her grandson on how to recharge her battery.Additionally, a wireless recharger was ordered for the patient.It is unknown if the issue is resolved.Rep clarified the report of ove rdischarge: the battery was fully depleted and in overdischarge mode.Her grandson brought her recharger to the hospital later that morning and rep worked with the patient and her grandson to charge her battery to 25-50% after completing the power on reset process.When rep turned the patient¿s battery on, the stimulation felt too high and the patient had obvious side effects like facial pulling on her left and right sides.Rep turned stimulation down from 4.5v to 1.5v and the patient still had side effects and reported feeling best when the stimulation was off.Rep did not feel comfortable making additional changes to stimulation and instead advised the patient to see a movement disorder neurologist for reprogramming.Rep left her battery off to maximize comfort given the circumstances.It is likely that this patient¿s stimulation had been off for several months considering that she was observed to be overstimulated with her current settings.
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 ESSENTI
• 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: 24665106
• Report Number: 3004209178-2026-05161
• Device Sequence Number: 9289635
• Product Code: PJS
• UDI-Device Identifier: 00763000100360
• UDI-Public: (01)00763000100360(17)210414
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2021
• 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: 03/08/2026
• Initial Report FDA Received Date: 03/23/2026
• Date Device Manufactured: 05/18/2020
• 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
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female