BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR

    MDR report key: 711707 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-13536
    Event Type
    Malfunction
    Date Received
    May 9, 2006
    Date of Event
    February 4, 2006
    Report Date
    February 4, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD TRANSVENOUS IMPLANTABLE LEAD FELL DUE TO SYNCOPE RESULTING FROM A VENTRICULAR TACHYCARDIA EPISODE, THE EPISODE WAS APPROPRIATE; HOWEVER, REVIEW REVEALED NOISE ON THE SHOCK CHANNEL. LEAD MEASUREMENTS WERE GOOD AND STABLE AND PATIENT MANEUVERS REPRODUCED THE NOISE. IN ADDITION, THE DEVICE DELIVERED ANTI-TACHY PACING, WHICH ACCELERATED THE RHYTHM. THIS RHYTHM WAS THEN TREATED WITH A 17 J SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other