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

Model Number	37612
Medical Device Problem Codes	Intermittent Continuity (1121); Failure to Deliver Energy (1211); Charging Problem (2892)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id wr9200.Product type recharger.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 for a few months now, they have been having a hard time recharging the patient's implantable neurostimulator (ins).Caller reported that the recharger would keep beeping like it was finding the ins and they would be able to intermittently charge the ins until 50% but would stop there because the patient would be annoyed by the beeping sound of the recharger.Caller also mentioned that they would notice that for quite a few times now, the therapy would turn off by itself even when the ins battery would still be at 50%.Caller stated that sometimes they would notice that the patient's symptoms would come back and when they go to check the therapy, they would see that it would be off, and they do not know why the therapy turns off by itself.Caller stated that the patient did not have any recent falls lately and the patient was not exposed to emi.Caller also stated that the recharger would not cause any error tones or show any error messages on the handset.Agent reviewed that the recharger seemed to be working as exp ected.Agent redirected patient to their hcp to further address the issue.Caller stated that they were at their patient's hcp yesterday for botox.

• 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 ; 7635265677
• MDR Report Key: 25001047
• Report Number: 3004209178-2026-07238
• Device Sequence Number: 9756921
• Product Code: MRU
• UDI-Device Identifier: 00763000519247
• UDI-Public: (01)00763000519247(17)230128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/27/2026

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: 01/28/2023
• 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: 04/24/2026
• Initial Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 03/10/2022
• 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: 32 YR
• Patient Sex: Female