BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

    MDR report key: 3854670 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11559
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    March 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INABILITY TO COMMUNICATE WITH THE DEVICE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO LOW BATTERY VOLTAGE. THE LOW BATTERY VOLTAGE WAS CAUSED BY HIGH CURRENT TRACED TO THE HYBRID. THE ROOT CAUSE OF THE FIELD EVENT WAS DUE AN ANOMALOUS COMPONENT ON THE HYBRID.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS NOT FEELING WELL AND PRESENTED TO THE CLINIC. THE ECG SHOWED NO PACING AND WITH A SLOW HEART RHYTHM. ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL WITH 2 DIFFERENT PROGRAMMERS. THE DEVICE WAS EXPLANTED. PATIENT CONDITION WAS GOOD FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330827 UNIFY QUADRA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3251-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention