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

Model Number	3387S-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
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 when the surgeon removed the electrode from the sterile box, they found that one of the electrode had a smaller pole spacing.There was no spare electrode in the operating room, so the possibility of replacing the part was offered.However, the logistical process until the new part arrived would take approximately 90 minutes.Considering the patient had skull trephination performed, the surgeon did not consider it safe for the patient to wait so long and chose to implant the electrode, even though it was non-compliant.The patient also had another with a larger spacing implanted, though the objective was implanting two electrodes with larger spacing (1.5mm spacing).Visual analysis and impedance testing were carried out, and it was found that there was continuity in all segments.
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 when the surgeon removed the electrode from the sterile box, which should be model 3387s-40 corresponding to the box, they found that the electrode had a smaller pole spacing, corresponding to the 3389s-40 electrode.There was no spare electrode in the operating room, so the possibility of replacing the part was offered.The patient was well anesthetized during the event.However, the logistical process until the new part arrived would take approximately 90 minutes.Considering the patient had skull trephination performed, the surgeon did not consider it safe for the patient to wait so long and chose to implant the electrode, even though it was non-compliant.The patient also had another with a larger spacing implanted, though the objective was implanting two electrodes with larger spacing (3387s-40 with 1.5mm spacing).Visual analysis and impedance testing were carried out, and it was found that there was continuity in all segments.The issue was not resolved.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 21455131
• Report Number: 2649622-2025-05315
• Device Sequence Number: 19984516
• Product Code: MHY
• UDI-Device Identifier: 00763000274320
• UDI-Public: 00763000274320
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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 Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA2WYMG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 02/05/2024
• 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
• Patient Age: 71 YR
• Patient Sex: Female