BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D

    MDR report key: 3090013 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01217
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    February 18, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF AN OUTPUT CIRCUIT DAMAGE ALERT WAS CONFIRMED IN THE LABORATORY. THE CHARGING AND DELIVERY CIRCUITS WERE FOUND TO BE NORMAL IN THE LABORATORY. IT WAS FOUND THAT THE ALERT WAS FALSE AND WAS CAUSED BY A FAILURE OF ONE OF THE DETECTION CIRCUITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED FOR DEVICE CHANGE OUT. THE NEW ICD WAS IMPLANTED SUCCESSFULLY. IT WAS NOTED THAT PRIOR TO IMPLANT DEFIB FUNCTION WAS NOT TESTED. AFTER IMPLANT, CAPACITOR MAINTENANCE WAS PERFOR MED AND AN ALERT MESSAGE STATING POSSIBLE OUTPUT CIRCUIT DAMAGE WITH A HIGH VOLTAGE IMPEDANCE OF 0 OHMS WAS OBSERVED. THE PACING AND HIGH VOLTAGE LEAD IMPEDANCES WERE NORMAL. THE POCKET HAD NOT BEEN COMPLETELY CLOSED AND ICD WAS EXPLANTED AND RE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192349 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention