BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEPT

    MDR report key: 13397016 · Received January 31, 2022

    Report

    Report Number
    3004209178-2022-01402
    Event Type
    Injury
    Date Received
    January 31, 2022
    Date of Event
    January 27, 2022
    Report Date
    January 31, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000420987
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CALLER STATED THE PATIENT IS INPATIENT AND NEEDS A BRAIN SCAN DUE TO DYSARTHRIA AND RIGHT SIDED WEAKNESS THAT STARTED YESTERDAY EVENING. THE CALLER SPOKE WITH PATIENT AND PATIENT'S HUSBAND WHO INDICATED THEY CAN'T PUT THE IMPLANTABLE NEUROSTIMULATOR (INS) INTO MRI MODE. THE CALLER WAS ABLE TO GO TO PATIENT'S BEDSIDE AND TECHNICAL SERVICES (TS) WALKED THEM THROUGH PUTTING THE INS INTO MRI MODE WHICH SHOWED MRI MODE NOT AVAILABLE WITH "ELIGIBILITY CANNOT BE DETERMINED" AND CODE 2511 2122 22 000; TS HAD CALLER BACK OUT OF MRI WORKFLOW AND CONFIRM PATIENT'S THERAPY WAS STILL ON. TS REVIEWED THAT INS CANNOT BE PUT INTO MRI MODE DUE TO POTENTIAL HIGH IMPEDANCE; AN OPEN CIRCUIT WAS DETECTED. THE PATIENT'S HUSBAND MENTIONED IN THE BACKGROUND THAT PATIENT WAS UNCOMFORTABLE AND THEY SAW MANUFACTURER'S REP (REP) YESTERDAY. TS REVIEWED TO HAVE INS CHECKED WITH TABLET TO INVESTIGATE THE IMPEDANCE ISSUE TO SEE IF AN MRI IS POSSIBLE - CALLER NOTED THEY ARE WORKING WITH REP AND HCP TO GET THIS COORDINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946132 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. B35200 00763000420987

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization