MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number	37603
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Collision (1429)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erosion (1750)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(6), ubd: 11-sep-2020, udi#: (b)(4).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
(b)(6) 2025: it was reported that one of the patient's leads has come through the scalp some.Caller doesn't have any further details about the nature of the erosion, size, etc.Impedances remain normal.2025-nov-03: additional information was received from a manufacturer representative (rep).The rep reported that the cause of the lead coming through the scalp was that the patient had squamous cell carcinoma (scc) a few years ago.They underwent wide excision with flap reconstruction with the leads re-tunneled around the flap.Patient recently sustained a fall with trauma to the l scalp, resulting in non-healing wound with hardware exposure.Patient completed course of antibiotics without improvement.Given exposed hardware, it was recommended to explant the devices in order to prevent potential development of intracranial infection.Device was explanted.Patient had a worsening of their parkinson's symptoms.

• Brand Name: ACTIVA
• Common Device Name: Stimulator, electrical, implanted, for parkinsonian tremor
• 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: 23581155
• Report Number: 3004209178-2025-19666
• Device Sequence Number: 9578359
• Product Code: MHY
• UDI-Device Identifier: 00643169864214
• UDI-Public: (01)00643169864214(17)190928
• 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: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 09/28/2019
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 04/02/2018
• 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: Male