MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. Percept; Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Model Number	B35200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	12/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient stated the dbs system had been removed due to recurrent infections occurring two to three times.The patient reported being hospitalized from christmas eve to christmas day, at which time the implanted neurostimulator battery was removed and a "cord" was left in place in an emergency situation.The patient stated that several weeks later the cord became infected, resulting in another hospitalization for approximately five days, and they removed the cord.The patient reported that after the infection initially appeared to clear, a new dbs system was implanted, but the patient did not realize it had become affected.The patient also stated that they still have the stitches now, and they were later readmitted because the antibiotics being given were not effective against the bacteria involved, and a picc line was placed to administer a different medication.See pe 709016640 for infection/explant/ leads remained/re-implantation planned.
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.

• Brand Name: Percept
• Common Device Name: Stimulator, Electrical, Implanted, For Parkinsonian Tremor
• 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 ; +1(763)526-5677
• MDR Report Key: 50314541
• Report Number: 3004209178-2026-13940
• Device Sequence Number: 13180503
• Product Code: MHY
• UDI-Device Identifier: 00763000916268
• UDI-Public: (01)00763000916268(17)271128
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2026

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?: No
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 08/19/2026
• Date Device Manufactured: 12/11/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male