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

Model Number	37612
Medical Device Problem Codes	Failure to Deliver Energy (1211); No Device Output (1435); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
Health Effect - Clinical Codes	Shaking/Tremors (2515); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/26/2026
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 about 3-4 days ago the patient started shaking really bad, and the shaking has gotten worse.The caller was under the impression that the therapy had turned off, but they were unable to turn the therapy back on because they were seeing a screen on the patient programmer that didn't make sense to them.The caller called manufacturer rep, and the rep told the caller that they would try to get ahold of someone to get an appointment for a replacement implantable neurostimulator (ins) because the rep was under the impression the ins battery might be over discharged.The caller was concerned about the patient's shaking and they needed to turn the therapy back on immediately.The caller initially got the 'poor communication' screen when they tried connecting to the ins.The caller repositioned the programmer but still could not connect to the ins.The caller replaced the aaa batteries in the programmer, then they saw the 'replace patient programmer batteries' warning screen.The caller noticed brown dust in the battery compartment as they were replacing the batteries of the programmer.The caller inserted brand-new aaa batteries, but they continued to get the 'poor communication' screen.The caller confirmed the recharger connected to the ins, and the ins battery was at least 25% charged.The recharger display also showed that the therapy was turned off.Due to the urgency of the situation, agent reviewed how to t emporarily activate the ins on/off buttons on the side of the recharger.The caller confirmed they were able to turn the therapy on, and the patient's shaking immediately calmed down.The caller stated that the patient's symptoms continued to improve as the call went on.Due to the programmer showing a persistent 'poor communication' screen, agent sent a request to the repair department to replace the patient programmer with kit.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 25011952
• Report Number: 3004209178-2026-07277
• Device Sequence Number: 21246562
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: (01)00613994934611(17)140414
• 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: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: 04/14/2014
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/06/2026
• Date Device Manufactured: 05/24/2013
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11....".
• Patient Age: 74 YR
• Patient Sex: Female