BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 4221013 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17450
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    August 29, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION SHOWED POST-PACED T WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. THE PATIENT HAD COMPLAINTS OF SYNCOPE. REPROGRAMMING WAS RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATES THAT THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702236 FORTIFY DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 1488TC/52, DC73974