BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 1895824 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04728
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 21, 2010
    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
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED RESET WAS CONFIRMED VIA REVIEW OF THE DEVICE IMAGE. REVIEW OF THE STORED EGM SHOWED CONTINUOUS DETECTION OF TACHY AND FIB, CHARGED AND DELIVERED SEVERAL THERAPIES. THE RESET MODE WAS NOT REPRODUCIBLE. IT IS BELIEVED THAT WHEN THE DEVICE CHARGED REPEATEDLY IN A SHORT PERIOD OF TIME, THE DEVICE'S BATTERY DID NOT HAVE SUFFICIENT TIME TO RECOVER. THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED SYSTEM. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING INAPPROPRIATE SHOCKS DUE TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. DURING ATTEMPT TO INTERROGATE THE DEVICE, IT WAS FOUND IN BACKUP VVI RESET MODE (BVVI). THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention