BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ST DR, DF4 CONNECTOR

    MDR report key: 2984506 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00542
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT FOLLOW-UP, DEVICE INTERROGATION REVEALED INEFFECTIVE THERAPIES FOR VT/VF. THE PHYSICIAN BELIEVES THAT EPISODE IS A VT STORM. ALL ELECTRICAL VALUES ARE NORMAL. THE DEVICE WAS REPROGRAMMED WITH ALL SHOCKS AT MAXIMUM ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87863 FORTIFY ST DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2235-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1