BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF4 CONNECTOR

    MDR report key: 3801327 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10994
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF NOISE ON WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TESTING EQUIPMENT AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE NOISE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS ELECTIVELY REMOVED, AND THE INITIAL COMPLAINT OF NOISE WAS ONLY AGAINST THE ASSOCIATED RV LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NOISE. PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279211 UNIFY CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention (B)(4)