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

Model Number	3708660
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id b35200 (serial: (b)(6)); product type: 0197-implantable neurostimulator; implant date (b)(6) 2023; explant date product id 3389s-40 (va1bk00); product type: 0200-lead; implant date (b)(6) 2016; explant date 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 patient came in for normal end of service battery replacement today.In pre-op, all impedances were normal, however, during the procedure there was a short (200 ohms) discovered between contacts 8 and 9 on the right hemisphere.Caller stated the patient was programmed with a double monopole (c+ 8- 9-) on those contacts.During the procedure, the extension tails were switched in the ports of the battery and it was determined that the issue was related to the lead or extension as opposed to the battery.The patient wasn't consented for anything other than the battery replacement so only the battery was replaced today.In post-op, the impedance measurement between 8-9 had decreased to 44 ohms.Caller stated programming was left as is on c+ 8- 9- and patient appeared to be getting symptom control for tremor with it noted that patient was still coming off sedation at the time.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.Caller stated (b)(6) university will be returning the explanted battery.Caller stated they plan to check-in with the patient in a week to see how their therapy is and check longevity.
Event or Problem Description
Additional information was provided by the manufacturer's representative indicating that the patient had an extension revision on sep.16.During the procedure, the new right extension appeared to resolve the short between contacts; however, the left lead was damaged while attempting to slide the boot cover up the lead, resulting in an intermittent short between contacts zero and one and a slightly higher impedance on contact three.The patient¿s battery was moved to the abdomen and replaced with a rechargeable battery.The physician elected to discard the extensions, but per hospital policy, the battery is being returned.
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 VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 25410069
• Report Number: 2649622-2026-16685
• Device Sequence Number: 13449632
• Product Code: MHY
• UDI-Device Identifier: 00613994749116
• UDI-Public: (01)00613994749116(17)201103
• 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: 2016
• 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,Followup
• Report Date (Section B): 07/13/2026

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: 11/03/2020
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 06/11/2026; 06/29/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 06/24/2026; 07/13/2026
• Date Device Manufactured: 11/03/2016
• 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...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female