BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVL-ADX ACTIVE-FIXATION STEROID-ELUTING TACHYARRHYTHMIA

    MDR report key: 724562 · Received June 9, 2006

    Report

    Report Number
    2938836-2006-00446
    Event Type
    Injury
    Date Received
    June 9, 2006
    Date of Event
    May 17, 2006
    Report Date
    May 17, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY ST. JUDE MEDICAL, INC., CRMD.

    Description of Event or Problem · 1

    THE ST. JUDE MEDICAL REPRESENTATIVE REPORTED THAT THE DEVICE WAS OVERSENSING NUMEROUS VENTRICULAR EVENTS RESULTING IN INAPPROPRIATE THERAPY. A LEAD DISLODGEMENT WAS SUSPECTED. THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVL-ADX ACTIVE-FIXATION STEROID-ELUTING TACHYARRHYTHMIA TRANSVENOUS DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL, INC., CRMD 1559/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention