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

Model Number	B35200
Medical Device Problem Codes	Electromagnetic Interference (1194); Failure to Interrogate (1332); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id tm91d0 serial# (b)(6) product type accessory 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 the patient had a cardioversion or defibrillation on the (b)(6) and now, patient cannot connect to implantable neurostimulator (ins) in therapy app on handset since friday, (b)(6) hcp said they got the device not found message when they tried to connect the communicator to the implanted neurostimulator.During the call, the patient representative restarted the handset and reset the communicator, but the patient was still unable to connect.The searching for device kept spinning and handset never advanced.The patient was redirected to their healthcare provider to further address the issue.Patient rep called repeating previously reported event information asking for troubleshooting assistance.The following troubleshooting steps were performed on the call: closed out of all running applications, confirmed bluetooth and location were enabled, hard reset the communicator.When caller reopened the mydbs therapy application and tapped connect the handset was able to connect to the communicator but they encountered message prompting them to set up links.Reviewed steps to place the communicator against the ins and press start.The searching for device message was spinning indefinitely without advancing.Caller confirmed they were confident they had the communicator directly against the ins.Caller confirmed they were using the correct handset, stating that the patient no longer had their old one.Caller reported the patient has not been able to connect to the ins ever since they had cardioversion procedure done in (b)(6).Patient also has a pacemaker implanted and caller confirmed they were placing the communicator over the dbs, not the pacemaker.Redirected to managing hcp to check device status.

• Brand Name: PERCEPT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 25446526
• Report Number: 3004209178-2026-09737
• Device Sequence Number: 13165251
• Product Code: PJS
• UDI-Device Identifier: 00763000642174
• UDI-Public: (01)00763000642174(17)251114
• Combination Product (Y/N): N
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 11/14/2025
• 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: 05/11/2026
• Initial Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 11/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 83 YR
• Patient Sex: Female