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

Model Number	37612
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that right chest battery is depleting quickly.Within two days after charging to 100%, patient programmer indicated ¿low battery¿.Patient denies falling or hitting dbs system components and stated no change in dystonia symptoms. will interrogate device on friday, feb.27, 2026, and check impedances and battery recharge data.
Event or Problem Description
Additional information received from rep indicating that the cause of the rapid battery depletion is unknown.What the session report says and what the patient is reporting is in conflict.The patient texted rep with his complaint on monday, (b)(6) 2026, stating that the night prior, (b)(6) 2026, he charged his right chest dbs device to 100% and the next day it was reading, ¿low battery¿.The interrogation only shows recharging on (b)(6) 2026, which device was charged from 75% to 100% and the next recharge was on (b)(6) 2026, which device started at 25% and charged to 100% over 3.22 hours.I believe his device would have depleted if not charged for 10 days.With suspected rapid depletion, rep ran electrode impedances and also ran them with stress on the system (palpated on device, palpated on device/ext connection, had patient turn his head to the right and hold and to the left and hold).No differences in impedance values were present with any of these scenarios.Patient reports no falls and symptoms control has been consistent and good.Repo rted ¿rapid battery depletion¿ has not occurred since the dates above.Rep repeats previously reported information including inconsistent recharging diary and notes that settings are really high currently and patient should have to charge every 3-4 days normally.
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 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: 24442878
• Report Number: 3004209178-2026-03250
• Device Sequence Number: 18705871
• Product Code: MHY
• UDI-Device Identifier: 00763000100360
• UDI-Public: (01)00763000100360(17)210428
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• 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,Followup,Followup
• Report Date (Section B): 06/26/2026

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: 04/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 02/27/2026; 06/18/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/02/2026; 06/26/2026
• Date Device Manufactured: 06/09/2020
• 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: 55 YR
• Patient Sex: Male