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

Model Number	37612
Medical Device Problem Codes	Intermittent Continuity (1121); Failure to Deliver Energy (1211)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient felt like the implant battery was turning off and on.Caller said the patient just moved into a new apartment and the patient didn't know if it was something in the apartment that was making the battery shut off.Caller asked if there was any that could tell that the battery was shutting off and on because the patient said it was going in waves like it would cut back on and off.Agent asked if caller had the patient's device to check the implant and caller said the implant was on, but the patient was still feeling like the device was cutting itself off.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.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 JUNCOS; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO JUNCOS; 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: 24816503
• Report Number: 3004209178-2026-06106
• Device Sequence Number: 9594324
• Product Code: MRU
• UDI-Device Identifier: 00613994934611
• UDI-Public: (01)00613994934611(17)131128
• 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: 2013
• 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): 04/08/2026

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: 11/28/2013
• 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: 04/07/2026
• Initial Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 01/09/2013
• 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
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female