BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 69147 · Received January 9, 1997

    Report

    Report Number
    2124215-1997-00307
    Event Type
    Malfunction
    Date Received
    January 9, 1997
    Date of Event
    September 19, 1996
    Report Date
    September 19, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    N030/031-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 (THE ICD MONITORS HEART FUNCTION BUT DOES NOT DELIVER THERAPY) DURING A ROUTINE FOLLOW-UP EXAMINATION. THE PHYSICIAN WAS ADVISED TO DISABLE THE 'DEACTIVATE THE ICD THROUGH MAGNET APPLICATION' FEATURE TO PREVENT RECURRENCE OF THIS PROBLEM. NOTE: THE VENTAK PRX PHYSICIAN'S MANUAL (CPI PUBLICATION 352927) P 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 55 YR Other THE DEVICE 6836/006008 WAS IMPLANTED 10-SEP-1993| THE DEVICE 0072/003195 WAS IMPLANTED 10-SEP-1993| THE DEVICE 0048/001175 WAS IMPLANTED 10-SEP-1993