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

Model Number	B35200
Medical Device Problem Codes	High impedance (1291); Unintended Collision (1429); Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
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 (pt) received service code 1703 on his patient programmer.Message reads : contact your physician.The neurostimulator is providing less than the requested therapy.Patient was seen by nurse provider and clinician tablet read stimulation settings out of range.Impedance test was conducted which displayed impedances > 5,000 ohms on 10a.In addition the patient reports that his battery longevity read 2.5 years in january of 2026.In march of 2026, battery life read 1 year.Today, battery life read 5 months.Nurse programmer removed segment 10 a from his therapeutic programming and reconfigured his adbs.Removing 10a from therapeutic program should allow for his longevity on his device to recover since his battery % reads 51 percent.His symptom control was excellent despite removing 10a.In addition, adbs was reconfigured to allow for the left to drive adaptation for both hemispheres.The right lead was attached to the left lead for adaptation.Patient symptom control was excellent post programming changes.Manufacturer representative (rep) reports the issue was not resolved at the time of report.
Event or Problem Description
The manufacturer representative provided additional information indicating that the high impedance may be related to a fall and that the issue is considered resolved, although a high impedance value remains on contact 10a.The shortened battery longevity to five months was attributed to the continued use of contact 10a with high impedance.High impedance was identified as the contributing factor; no additional steps beyond those previously described were reported.The information was confirmed and provided by the physician.
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 ; 7635265677
• MDR Report Key: 25450230
• Report Number: 3004209178-2026-09758
• Device Sequence Number: 21009710
• Product Code: MHY
• UDI-Device Identifier: 00763000642174
• UDI-Public: (01)00763000642174(17)251014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2025
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/10/2026
• Date Device Manufactured: 10/27/2023
• 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: 61 YR
• Patient Sex: Male