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

Model Number	37603
Medical Device Problem Codes	Energy Output Problem (1431); Loss of Data (2903); Data Problem (3196)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Lethargy (2560)
Date of Event	11/02/2025
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 the caller stated the patient suddenly began experiencing issues such as lethargy and reduced motion.After contacting the healthcare provider's office and speaking with the nurse practitioner, the caller was redirected to contact the manufacturer.There had been no recent medical tests, procedures, or exposure to large amounts of emi.With guidance, the caller checked the left implantable neurostimulator (ins), which was on and functioning correctly, but when checking the right ins, the screen showed it was on and okay, although the amplitude for group b was set to 0.0, which was the group the patient had been using.Attempts to increase the setting resulted in a "upper limit has been reached" message, and troubleshooting did not resolve the issue.The caller also noted the presence of group a for the right side and was redirected to contact the nurse practitioner to update on group b and seek guidance on using group a and the appropriate parameters.Patient services provided the phone number for stimulation technical support to be given to the nurse practitioner for further questions.
Additional Manufacturer Narrative
Continuation of d10: product id 37603, serial# nlb774123h, implanted: (b)(6) 2023, product type: implantable neurostimulator.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
Additional information was received from the healthcare provider (hcp) that the cause was unknown.They reported that the patient was able to resolve the problem on their own and is now doing fine.

• 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: 23640627
• Report Number: 3004209178-2025-20067
• Device Sequence Number: 21283418
• Product Code: MHY
• UDI-Device Identifier: 00763000100353
• UDI-Public: (01)00763000100353(17)211228
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 12/28/2021
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/05/2025
• Date Device Manufactured: 07/06/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11."
• Patient Age: 75 YR
• Patient Sex: Female