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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date is not known.Please see b5 for approximate date range, if applicable.Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id (b)(4).(lot: j0519661v); product type: 0200-lead; implant date (b)(6) 2005; explant date brand name activa; product id (b)(4).(lot: j0519663v); product type: 0200-lead; implant date (b)(6) 2005; explant date 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 a healthcare professional stated that impedance measurements on the right implanted neurostimulator were out of range during evaluation.Contacts 9c, 10a, 10b, 10c, and 11 were reported to have impedance values ranging from 5k to 10k.No environmental, external, or patient-related contributing factors were identified; however, it was noted that the patient had longstanding implanted leads (since 2005).The healthcare professional reported that the affected contacts were not used for programming.No surgical intervention occurred, and no additional information was expected from the healthcare professional.
Additional Manufacturer Narrative
Continuation of d10: product id b35300 lot# serial# (b)(6), implanted: (b)(6) 2026, product type implantable neurosti mulator product id 3387-40 lot# j0519661v serial#, implanted: (b)(6) 2005, product type lead product id 3387-40 lot# j0519663v serial#, implanted: (b)(6) 2005, 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.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
Rep confirms that this was discovered during a regular device check up.Additional information received where representative mentioned they just did a battery change from primary cell to rechargeable cell and everything looked good in terms of connectivity and impedances, but then the hcp went to close and the connectivity test suddenly showed a lack of connectivity.Rep.Said they had run the impedance test again and everything looked good except for contact 11, rep ran the impedance test again and saw the implantable neurostimulator (ins) now had some impedance results that were elevated.Contact 11 had 38,000(monopolar) ohms.Contact 10 a-c had impedance over 10,000 ohms.Rep.Said left gpi monopolars are all good, but now, 2c and 2b and 2a and 2b are at 10,000.Rep.Said the "they were not like that, but the more they run impedance, the more impedance issues come up.Further troubleshooting could not be performed because hcp had already closed.Tech services asked what solution had been used for pocket cleaning and rep.Said an antibiotic solution.

• 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: 24948310
• Report Number: 3004209178-2026-06936
• Device Sequence Number: 10029491
• Product Code: MHY
• UDI-Device Identifier: 00763000420987
• UDI-Public: (01)00763000420987(17)221128
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/06/2026

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 Expiration Date: 11/28/2022
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 04/24/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 04/24/2026; 05/06/2026
• Date Device Manufactured: 12/11/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."; "SEE H11...."; SEE H11...
• Patient Sex: Male