MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	3387S-40
Medical Device Problem Codes	Break (1069); High impedance (1291); Low impedance (2285); Material Deformation (2976)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It is being reported that the patient¿s right brain lead was visibly fractured.This was determined during interoperative examination and testing of impedance values.Impedances were checked, pre-procedure and found to be abnormal.Patient had reported loss of symptom control approximately one month ago.Exact date is unknown.Patient started experiencing significant tremor on the left side of his body that was not resolved by changing programming.X-rays were taken and a noticeable bend/kink in the right brain lead was visible.Surgical intervention was opted for to examine the right brain lead and test interoperative impedances.Upon testing the right brain lead impedances were abnormal on all electrodes.Issue is not resolved at time of this report.It is undetermined if this time if the right brain lead will be replaced in the future.It is also undetermined if the patient is a surgical candidate for another lead replacement.
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.
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
Additional information was received from the manufacturing representative (rep).Rep reported that the cause of the fractured lead was unknown.Rep reported that the patient is scheduled for a lead replacement on (b)(6) 2025.
Additional Manufacturer Narrative
D3: product id# 3387s-40 lot:va0qxld the returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Reliability non-conformance.Conductor(s) stretched.Conductor pairs 2-1 and 2-3 are shorted.All conductors broken 75.0 cm from distal end (overstress).Wire broken in body of lead.Insulation torn under electrode.Continuity acceptable.Suspected body fluid observed in 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 PARKINS
• 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: 23072779
• Report Number: 2649622-2025-25796
• Device Sequence Number: 10064647
• Product Code: MHY
• UDI-Device Identifier: 00643169313514
• UDI-Public: (01)00643169313514(17)170905(10)VA0QXLD
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2025

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: 09/05/2017
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA0QXLD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 10/20/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 68 KG