BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D, DF4 CONNECTOR

    MDR report key: 3220404 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04549
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 31, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE DEVICE WAS TESTED ON THE BENCH AND HIGH CURRENT DRAW WAS OBSERVED. IT IS BELIEVED THAT THE CAUSE WAS DUE TO AN ANOMALOUS COMPONENT ON THE HYBRID. (B)(6). (B)(4). FAILURE (EVENT) OBSERVED DURING ANALYSIS.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321016 UNIFY CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3235-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1