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

Model Number	B35200
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id b3400060 lot# serial# (b)(6).Implanted: (b)(6) 2026.Explanted: product type extension product id b3400060m lot# serial# (b)(6).Implanted: (b)(6) 2026.Explanted: product type extension section d information references the main component of the system.Other relevant device(s) are: product id: b3400060, serial/lot #: (b)(6), ubd: 15-apr-2028, udi#: (b)(4) ; product id: b3400060m, serial/lot #: (b)(6), ubd: 17-apr-2028, udi#: (b)(4).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 impedance issues were observed during an extension implantation procedure.During the procedure, impedance issues were noted on both sides.Troubleshooting steps included disconnecting the extensions from the leads, cleaning and suctioning the ports, and reconnecting the components; however, the issues persisted.The extensions were also disconnected from the implanted pulse generator, and the same cleaning and reconnection process was repeated without resolution.Additional impedance checks performed during the remainder of the procedure showed some electrodes returning to normal values, although not all contacts cleared.Impedance issues were reported to continue following completion of the surgery.The manufacturer representative provided additional information indicating that the impedances were high and that, due to the segmented pattern of the impedance findings, an air bubble in the brain was considered a likely contributing factor.Resolution status and patient outcome were not known.The information was confirmed by the provider in the operating room.

• 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: 25700392
• Report Number: 3004209178-2026-11197
• Device Sequence Number: 18578758
• Product Code: MHY
• UDI-Device Identifier: 00763000916268
• UDI-Public: (01)00763000916268(17)280128
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2026

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 Model Number: B35200
• Device Catalogue Number: B35200
• 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: 06/05/2026
• Supplement Date Received by Manufacturer: 06/17/2026; 06/17/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 07/02/2026; 07/14/2026
• Date Device Manufactured: 02/09/2026
• 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...."
• Patient Age: 70 YR
• Patient Sex: Male