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

Model Number	37612
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Codes	Shaking/Tremors (2515); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient lives at a rehab facility and the step mom is the only one that has access to the handset that can check the status of the batteries.Caller states the other night patient was shaking and the following day patient was drooling.The step mom went home and got the cell phone and found one side was off and when they turned it on it was at 50% because the patient had started charging it.They were able to turn therapy on.Caller states they are relying on the nurses at the rehab to make sure patient is charging the implant which is a joke.When they sit there with patient and do it, patient will just move and it goes off.They want it to almost magnetize and stick but it doesn't and it will constantly start beeping again especially when the patient is sh aking.Caller is wondering if there is anything else they can purchase.Caller states it would be easier to have two handsets , one to leave at the rehab but they are afraid it may get lost so would need one to keep in their home also.Agent reviewed they could check with the doctor about another handset but unknown if the doctor would be able to do that.Agent will contact field to inform them.Patient's spouse called and said has an additional question that doesn't think was asked when daughter in law called earlier.Caller said was told some information that device will need special programming if the therapy turns off more than twice.Reviewed over discharge information with caller.Caller also repeated information that the patient lives in a nursing home and that therapy has been off a few times.Agent explained that when implanted battery level drops down below a certain percentage that stimulation will automatically turn off.Caller also requested name of managing physician.Caller was redirected to contact patient's managing physician for current rep information.
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: 24793113
• Report Number: 3004209178-2026-05979
• Device Sequence Number: 9727691
• Product Code: MHY
• UDI-Device Identifier: 00763000519247
• UDI-Public: (01)00763000519247(17)230814
• 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: 2023
• 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): 04/06/2026

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: 08/14/2023
• 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: 03/10/2026
• Initial Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 09/27/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Male