MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	3387S-40
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Serious Injury
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 after a deep brain stimulation procedure, the patient's lead circuit was found to be disconnected.The operation was performed again on (b)(6) 2024, to replace the lead 3387s-40.The issue was resolved with the replacement of the lead.No patient complications have been reported as a result of this event.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; 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: 21018710
• Report Number: 2649622-2024-34928
• Device Sequence Number: 4008653
• Product Code: MHY
• UDI-Device Identifier: 00763000274320
• UDI-Public: 00763000274320
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2024

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: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA2YY8Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 12/26/2024
• Date Device Manufactured: 05/31/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female