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

Model Number	B35200
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)
Health Effect - Clinical Codes	Discomfort (2330); Electric Shock (2554)
Date of Event	04/04/2026
Type of Reportable Event	Serious Injury
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 was seen by healthcare provider (hcp) today, on the clinician programmer, it shows 22% remaining on imp lantable neurostimulator (ins) longevity.Caller reports the patient programmer shows 4 battery bars remaining.Caller reports patient did not see eri message.Reviewed longevity caller reported patient is experiencing intermittent shocks/ vibrations underneath the dbs device for the past 5 days lasting just a few seconds.Caller stated patient has not changed dbs settings and is not programmed with adaptive stim and is only on constant dbs.Caller also stated there is no trauma, normal impedance.Caller is not with the patient.Caller reports patient is scheduled for ins replacement to rechargeable ins, currently no date reviewed log files.The patient was redirected to their healthcare provider to further address the issue.Additional information received from a rep indicating that surgery was initially planned for normal battery depletion and is also how they will address the intermittent shock issue.No date for surgery has been confirmed.Rep reported the cause of the ins showing 22% and 4 bars is normal and not an actual issue so no actions were taken.

• 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: 24946429
• Report Number: 3004209178-2026-06932
• Device Sequence Number: 17459087
• Product Code: MHY
• UDI-Device Identifier: 00763000519216
• UDI-Public: (01)00763000519216(17)240328
• 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: 2022
• 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): 04/21/2026

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: 03/28/2024
• 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: 04/09/2026
• Initial Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 04/08/2022
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male