BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA CRT-D

    MDR report key: 3791057 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10446
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: UPON RECEIPT, THE DEVICE WAS FOUND IN BACKUP VVI. THE DEVICE IMAGE WAS FOUND TO BE CORRUPTED. THE DEVICE WAS TESTED USING AUTOMATED TESTING EQUIPMENT AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE BACKUP VVI COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYMPTOMATIC PATIENT PRESENTED IN THE ER AFTER RECEIVING SEVERAL INAPPROPRIATE SHOCKS. DURING INTERROGATION THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. THE DEVICE AND THE LEAD WERE EXPLANTED AND REPLACED WHEN FIRMWARE DOWNLOAD WAS UNSUCCESSFUL. THE PHYSICIAN SUSPECTS THE SHOCKS WERE DUE TO A LEAD ISSUE. PATIENT CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269130 QUADRA ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3265-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 6947-58, TDG322045V