BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR

    MDR report key: 3854654 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11586
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 14, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A MERLIN.NET TRANSMISSION OF MULTIPLE EPISODES OF VF THAT WERE BROKEN WITH ATP. THE THIRD EPISODE APPEARED TO BE MYOPOTENTIAL OVERSENSING. THE PATIENT RECEIVED INAPPROPRIATE ATP THERAPY. THE ICD WAS REPROGRAMMED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330910 FORTIFY VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention