BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 4760351 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04610
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    February 20, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A PATIENT PRESENTED FOR A VT ABLATION, AN ALERT FOR LONG CHARGE TIME WAS OBSERVED. THE PATIENT COULD NOT BE CONVERTED BACK TO SINUS WHEN VT WAS INDUCED. THE PATIENT HAD TO BE EXTERNALLY DEFIBRILLATED. A SUBSEQUENT CAPACITOR MAINTENANCE WAS UNSUCCESSFUL. TELEMETRY INTERFERENCE AND DAMAGE DUE TO EXTERNAL DEFIBRILLATION WERE SUSPECTED. THE DEVICE BEHAVED NORMALLY AFTER THE ABLATION PROCEDURE WITH NORMAL CHARGE TIMES AND NORMAL TELEMETRY. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303635 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3265-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR