MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA ACTIVA; Stimulator, electrical, implanted, for essential tremor

Model Number	3708660
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Erosion (1750)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient has a lead that is exposed at the incision site, later stating it is still in the body, but states it is exposed to air.Tech services reviewed mri labeling; however, rep requested an engineer contact them as soon as possible.Rep states the physician wants to pull the wires and cut them, but the patient has an mri scheduled tomorrow.Rep was unsure when this began.Rep stated the impedances were normal last time he met with the patient.Additional information received from rep indicating on 1/22/26, the lead and extension were explanted, and a plug was placed in the implant.The open wound was closed but the patient has to wait 3 months to get implanted.Rep clarifies that the connection point between the lead and extension on the left side of the patient's head behind the ear is the location of the erosion.The devices have not migrated from their implanted position.
Additional Manufacturer Narrative
Continuation of d10: product id: 3387-40 lot# v001440, implanted: (b)(6) 2006, explanted: (b)(6) 2026, product type: lead.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 essential tremor
• 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: 24316414
• Report Number: 2649622-2026-04032
• Device Sequence Number: 17359266
• Product Code: PJS
• UDI-Device Identifier: 00763000236830
• UDI-Public: (01)00763000236830(17)280724
• 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: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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 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: 01/19/2026
• Initial Report FDA Received Date: 02/11/2026
• Date Device Manufactured: 07/24/2024
• 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 Sex: Female