MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	B35200
Medical Device Problem Codes	Break (1069); High impedance (1291)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there were high impedances on the right subthalamic nucleus (stn) in a patient.Additionally, there was an increase in tremor in the patient's left hand within the last 1-3 months, and the implantable neurostimulator (ins) battery level was at 25%.Technical services reviewed the impedance values (c/8 7700, c/9 7454, c10 7527, c11 8097 and 8/11 4344, 8/10 3031, 8/9 1462, 9/11 3441, 9/10 1953, 10/11 1094) and discussed the potential impact on battery depletion.They considered using the 8/9 contact as the patient was currently programmed at c/8 @ 3.4ma.It was suggested that the managing healthcare provider be prepared to test the lead/extension connection and/or lead at the time of future ins 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
Section d10 references: product id: 3389s-40, lot# va2a6k7, implanted: (b)(6) 2020, explanted: (b)(6) 2025, product type 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the cause of the impedance issue was due to the lead being physically broken.The hcp didn¿t know if the break was at the end that connected to the extension or on the contacts of the lead itself.The system was explanted and may be reimplanted later this year.
Additional Manufacturer Narrative
B5 updated with additional information.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received from a manufacturing representative (rep).Rep reported that they were recently notified that patient will be explanted on (b)(6) 2025 and will be re-implanted the following day.Information was received from a manufacturing representative (rep).Rep states the reason for the revision was the patient was having an impedance issue on one of the legacy leads bipolar 10/11.The extension revision was done (b)(6) 2025 to see if that resolved the issue but it did not.The patient's extensions and leads were completely explanted today and what remains today is the ins and two extensions that are capped--the leads are to be placed tomorrow.The caller noted that there were no issues with the other lead that was explanted (the lead that did not have the 10/11 impedance issue) but the decision was to explant everything today to move to the directional leads.The reason for the call was they want to do an mri but the mri facility is pushing back on pursuing this mri due to no leads being present.Agent reviewed guidelines and noted there is nothing in the guidelines that would explicitly allow for an mri to be done with only the implant and two capped extensions.Agent provided email with documents.

• Brand Name: PERCEPT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 21168597
• Report Number: 3004209178-2025-00877
• Device Sequence Number: 14536933
• Product Code: MHY
• UDI-Device Identifier: 00763000253363
• UDI-Public: 00763000253363
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2025

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: 07/28/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/19/2025; 03/06/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/27/2025; 03/14/2025
• Date Device Manufactured: 08/04/2020
• 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: 57 YR
• Patient Sex: Male