BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 74088 · Received January 16, 1997

    Report

    Report Number
    2124215-1997-00779
    Event Type
    Malfunction
    Date Received
    January 16, 1997
    Date of Event
    August 1, 1996
    Report Date
    November 1, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    N030/031-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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 CAN DETECT ARRHYTHMIAS BUT WILL NOT DELIVER THERAPY) WHEN INTERROGATED AT A NORMAL FOLLOW-UP VISIT. THE ICD WAS REPROGRAMMED TO MONITOR + THERAPY MODE, AND REMAINED IMPLANTED AT THE TIME. NOTE: THIS INFORMATION WAS RECEIVED 'SEVERAL MONTHS' AFTER THE EVENT OCCURRED. 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 69 YR Other THE DEVICE 0074/001249 WAS IMPLANTED 13-JUL-1993