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

Model Number	37612
Medical Device Problem Codes	Overheating of Device (1437); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id neu_recharger_acc.Serial# unknown: product type recharger product id a620.Serial# unknown: product type software 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 a patient experienced dull pain, burning sensation, and a heating sensation during recharging.The issue was r eported to have started a couple of months prior.There were no recent therapy setting changes and no reported fall or trauma.Impedances were checked and reported as fine and the patient was reported to be receiving good symptom relief.The patient was evaluated by a physician and the pocket site was noted to look fine with no problems.Troubleshooting guidance included recommending charging with clothing over the implantable neurostimulator site, performing more frequent but shorter charging sessions, and a plant to transition from a legacy recharger to a wireless recharger.Additional information has been received that the patient received a wireless recharger but they could not get it to pair with the handset.The patient rep had already spoken with manufacturer rep, who told the caller that the patient might need a newer version of the handset.Agent had caller check handset (j3) and the recharger app was not installed.Agent re-opened case and sent request to the repair department to replace the handset.Additional information received from rep indicating that heating was caused by an external device issue regarding the insr.New wr and communicator was sent to patient who is satisfied with the upgrade.Issue resolved.

• 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: 25431084
• Report Number: 3004209178-2026-09652
• Device Sequence Number: 10373651
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: (01)00643169864238(17)200914
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: 09/14/2020
• 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: 05/15/2026
• Initial Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 10/24/2019
• 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