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

Model Number	37603
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient said his barber noticed an exposed wire.Since dbs is his only implant, it is almost certainly a dbs lead wire.Patient's neurologist is bringing him in today to examine the area, check for infection, and refer to the patient's implanting neurosurgeon if needed.Issue is unresolved at time of this report.Additional information received from rep indicating the lead/extension junction site is exposed.Mri eligibility form has been filled out and impedance are within normal limits.Caller reports patient is scheduled for mri; neurosurgeon will be explanting the entire system and re-implant later.Caller reports patient has finished with the mri scan, 15 minutes post scan.Caller reports patient had no issue or complaints.Impedance re-check and was normal.Caller reports patient turned stimulation back on.Patient has follow up appointment with physician, will be meeting with plastic surgeon since patient had lead/extension exposed.Patient also indicated all components will be explanted, let the site heal for period of time, after the healing process, patient will then have the system re-implant.
Additional Manufacturer Narrative
Continuation of d10: product id: 37603 lot# serial# (b)(6), implanted: (b)(6) 2025.Product type: implantable neurostimulator.Product id: 37603, lot# serial# (b)(6), implanted: (b)(6) 2025, product type: implantable neurostimulator.Product id: 3387s-40 lot# va1ks8p, implanted: (b)(6) 2019, product type: lead.Product id: 3387s-40 lot# va1h8hw, implanted: (b)(6) 2020: product type: lead.Product id: 3708660, lot# serial# (b)(6), implanted: (b)(6) 2020, product type: extension.Product id: 3708660, lot# serial# (b)(6), implanted: (b)(6) 2019, product type: extension.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 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: 24388895
• Report Number: 3004209178-2026-02767
• Device Sequence Number: 13322056
• Product Code: MHY
• UDI-Device Identifier: 00763000519230
• UDI-Public: (01)00763000519230(17)250514
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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 Expiration Date: 05/14/2025
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 11/14/2023
• 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