BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 68998 · Received January 9, 1997

    Report

    Report Number
    2124215-1997-00158
    Event Type
    Malfunction
    Date Received
    January 9, 1997
    Date of Event
    August 21, 1996
    Report Date
    August 22, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    N030/031-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS VENTAK PRX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND IN MONITOR ONLY MODE (ICD WILL SENSE EVENTS BUT NOT DELIVER THERAPY). THE ICD HAD RECORDED FOUR EPISODES OF VT AND TWO EPISODES OF VF WHILE THE ICD WAS IN MONITOR ONLY MODE. ALL OF THE ARRHYTHMIAS DURING THIS TIME WERE SPONTANEOUSLY CONVERTED TO SINUS RHYTHM WITHOUT THERAPY BEING DELIVERED. NOTE: THE VENTAK PRX PHYSICIAN'S MANUAL (CPI PUBLICATION 352927) PAGE 74 STATES: '...PATIENTS SHOULD AVOID EQUIPMENT OR SITUATIONS WHERE THEIR DEVICE WOULD BE EXPOSED TO STRONG (>10 GAUSS) MAGNETIC FIELDS.' THIS ICD FALLS UNDER FDA SAFETY ALERT FDA #N030/031-5. THE PHYSICIAN WAS NOTIFIED ON 4/18/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS 1705 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other THE DEVICE 0074/003138 WAS IMPLANTED 12-DEC-1994