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

Model Number	B35200
Medical Device Problem Codes	Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Malposition of Device (2616)
Health Effect - Clinical Codes	Erosion (1750); Erythema (1840); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.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; 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the patient had to have cpr on june 26th and by july they started seeing a redness in the area and by august it started puffing up almost like swelling and it looks like they have a 3rd boob growing, they can see the shape of the battery in the puffed up area, they can also see the wires almost like it is going to burst through their skin.The patient was redirected to their healthcare provider to further address the issue.Patient also reported: because of their parkinson's they are getting a lot of cramping, shocking that runs through their body that they have never had before and they are wondering if this thing is floating around and breaking blood vessels and giving them shocks that are going through their legs, they did not have that before and it is being done on their right side and the right side is not controlled by the dbs just the left side.Patient asked: could the components of the implanted system break loose from where they are specifically implanted.Reviewed information about adverse events.Patient reported they are in a nursing home now because they can't function properly because of this and they would like to get away from current hcp.Offered and sent listings.Redirected to their doctor.
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 provided regarding a patient call about concerns that the ¿wires¿ looked like they were about to fail; the patient had already seen the hcp, who confirmed the implant was fine, and also reported not receiving parkinson¿s disease medications consistently; the agent reviewed general therapy information and the role of patient services, redirected the patient to the hcp for further evaluation and management, and the patient then disconnected the call.
Additional Manufacturer Narrative
Continuation of d10: product id 3708660 serial# (b)(6) implanted: (b)(6) 2020 product type extension 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: 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: 23672055
• Report Number: 3004209178-2025-20239
• Device Sequence Number: 9761440
• 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,Followup
• Report Date (Section B): 01/14/2026

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 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 12/26/2025
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 01/09/2026; 01/14/2026
• 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...."; SEE H11...
• Patient Age: 74 YR
• Patient Sex: Female