BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 1895808 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04725
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 25, 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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED NOISE WAS VERIFIED VIA STORED ELECTROGRAMS. THE DEVICE WAS TESTED ON THE BENCH AND NO NOISE WAS DETECTED. THE DEVICE WAS TESTED IN THE AUTOMATED TESTING EQUIPMENT AND NO ANOMALY WAS DETECTED. THE CAUSE OF THE NOISE WAS UNDETERMINED, HOWEVER A LEAD CONNECTION ISSUE IS SUSPECTED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO INAPPROPRIATE THERAPY AND NOISE. THE PHYSICIAN THOUGHT THE SETSCREW WAS DAMAGED DURING IMPLANT.

    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 46 YR Required Intervention