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

Model Number	B35200
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Cardiac Arrest (1762); Convulsion/Seizure (4406)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient stated they had a seizure on (b)(6) (year not confirmed), during which they experienced cardiac arrest, received cpr, and were revived.The patient reported that since then, their implant had moved, which led to bruising they attributed to broken blood vessels, believing the wires near their carotid artery were affected by the cpr.The patient stated their healthcare provider had examined the implant and confirmed it was fine.The patient also mentioned inconsistent administration of parkinson's disease medications.Patient services reviewed general therapy information and the role of patient services, then redirected the patient to their healthcare provider for further evaluation.The patient became distraught and deliberately disconnected the call before further information could be reviewed.*see pe (b)(4) for cpr on (b)(6), wires issue*.
Additional Manufacturer Narrative
B3: 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 3708660 (serial: (b)(6)); product type: 0191-extension; implant date (b)(6) 2020 brand name activa; product id 3389s-40 (lot: va26nwg); product type: 0200-lead; implant date (b)(6) 2020.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
Continuation of d10: product id 3708660 serial# (b)(6) implanted: (b)(6) 2020 product type extension product id 3389s-40 lot# va26nwg implanted: (b)(6) 2020 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
It was reported that the patient reported experiencing a seizure on (b)(6) (year not confirmed), stating that they died as a result of the event, received cpr, and were subsequently revived.The patient stated that since this incident, their implant has moved, which they believe led to extensive bruising.The patient attributed the bruising to broken blood vessels, explaining that the implant wires were close to the carotid artery and may have been damaged during cpr.The patient further reported that they had already followed up with their hcp, who advised that the implant was functioning properly.The patient also stated that they were not receiving parkinson¿s disease medications consistently.The agent reviewed general therapy information and the role of patient services, and redirected the patient to their hcp for further evaluation.Before additional information could be reviewed, the patient became distraught and intentionally disconnected the call.

• 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: 24017536
• Report Number: 3004209178-2026-00402
• Device Sequence Number: 9201734
• Product Code: MHY
• UDI-Device Identifier: 00763000253363
• UDI-Public: (01)00763000253363(17)220428
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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 Expiration Date: 04/28/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/23/2026
• Date Device Manufactured: 04/29/2020
• 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...
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female