BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 19214002 · Received April 30, 2024

    Report

    Report Number
    3004209178-2024-10016
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    June 28, 2022
    Report Date
    April 30, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000519216
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEIR IMPLANTER HAD AN ISSUE IN THE OPERATING ROOM ON IMPLANT DATE. THE PATIENT THINKS THE ISSUE WAS RELATED TO IMPEDANCE BECAUSE THEIR PROVIDER (HCP) TOLD THEM THE IMPLANTABLE NEUROSTIMULATOR (INS) HAS HAD PROBLEMS WITH IMPEDANCE SINCE IMPLANT DATE. THE PATIENT DID NOT KNOW ANYTHING ELSE ABOUT THE IMPEDANCE ISSUE OTHER THAN IT CAUSING THE INS BATTERY TO DRAIN QUICKLY. THE PATIENT MENTIONED THAT THEIR HCP DID AN IMPEDANCE CHECK YESTERDAY, BUT THEY DID NOT KNOW THE RESULTS. THE PATIENT'S REASON FOR CALLING WAS BECAUSE THEIR ORAL SURGEON ASKED THEM TO HAVE AN MRI, BUT THE PATIENT WAS NOT SURE IF IT WAS SAFE FOR THEM TO GET AN MRI. THE PATIENT DID NOT HAVE AN MRI ELIGIBILITY REPORT, SO AGENT REVIEWED HOW TO USE THE DBS THERAPY APP TO DETERMINE MRI ELIGIBILITY. THE THERAPY APP SHOWED THE 'MRI MODE NOT AVAILABLE' SCREEN WITH THE FOLLOWING INFORMATION CODE: 2521 2122 22 000. AGENT REVIEWED THAT THE INFORMATION CODE INDICATED THAT AN OPEN CIRCUIT WAS DETECTED. AGENT REVIEWED THAT THE PATIENT SHOULD NOT HAVE AN MRI AND REDIRECTED THE PATIENT TO THEIR HCP TO FURTHER ADDRESS THE ISSUE. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143507 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. B35200 00763000519216

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female