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

Model Number	37612
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date is not known.Please see b5 for approximate date range, if applicable.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 information was received from a manufacturer representative stating the patient resided in a nursing facility where staff had reportedly refused to charge the implanted neurostimulator.The representative initially believed the battery was depleted but later reported that the device had entered an overdischarge state.The representative also reported observing a message indicating the recharger was missing the target.Attempts to connect using the patient programmer and a clinician tablet were unsuccessful.Technical services reviewed instructions for initiating physician recharge mode.
Event or Problem Description
2026-may-05 rtg1041741 (rep): it was reported that information was received from a manufacturer representative stating the patient resided in a nursing facility where staff had reportedly refused to charge the implanted neurostimulator.The representative initially believed the battery was depleted but later reported that the device had entered an overdischarge state.The representative also reported observing a message indicating the recharger was missing the target.Attempts to connect using the patient programmer and a clinician tablet were unsuccessful.Technical services reviewed instructions for initiating physician recharge mode.2026-may-07 e1 (rep): the manufacturer representative provided additional information indicating that the overdischarge condition was addressed by following the overdischarge recovery procedure and charging the battery to 50%.Staff at the rehabilitation facility were also instructed on proper charging procedures.The patient experienced stiffness associated with the overdischarge.The date the condition was first observed by the physician is unknown.The information was confirmed and provided by the physician.
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: 25107379
• Report Number: 3004209178-2026-07827
• Device Sequence Number: 18726758
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: (01)00643169864238(17)200414
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: 04/14/2020
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/21/2026
• Date Device Manufactured: 05/23/2019
• 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
• Patient Sex: Male