MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number	B35200
Medical Device Problem Code	Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Discomfort (2330); Numbness (2415); Tics/Tremor (4425)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
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
It was reported that patient had a good shock at work as an electrician about 2.5 - 3 months ago that caused a return of symptoms and tics.Patient was still able to work.Patient also experience weakness and numbness on left side of body that has been progressing.Patient went to hospital on saturday and was transferred to (b)(6).Mri to be done for possible stroke.Caller met with patient on (b)(6) and made some programming changes that helped with the tics but not the weakness and numbness.Caller reported one of patient's tics is punching his neck where the extension is but caller checked the system integrity and no issues reported.Additional information received from rep clarifying that patient went to hospital for right sided weakness and numbness, mri showed no sign of stroke per hcp.It is unknown if manufacturer device is causal or contributory to these symptoms.Patient was originally shocked on the job due to touching a live outlet while working on their jobsite unrelated to their dbs system.The exact date of this shock is unknown but patient reports that it was a couple months ago.Symptoms remain ongoing.

• 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 ; 7635265677
• MDR Report Key: 25005116
• Report Number: 3004209178-2026-07259
• Device Sequence Number: 9774241
• Product Code: MHY
• UDI-Device Identifier: 00763000420987
• UDI-Public: (01)00763000420987(17)230914
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: 09/14/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2026
• Initial Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 09/27/2021
• 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
• Patient Age: 23 YR
• Patient Sex: Male