BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 95541 · Received May 8, 1997

    Report

    Report Number
    2124215-1997-01244
    Event Type
    Malfunction
    Date Received
    May 8, 1997
    Date of Event
    February 12, 1997
    Report Date
    February 12, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    N030/031-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT AT A VENTAK PRX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN MONITOR ONLY MODE (THERAPY DELIVERY DISABLED) WHEN INTERROGATED AT A NORMAL FOLLOW-UP VISIT. AFTER INTERVIEWING THE PATIENT, IT IS BELIEVED THAT THE ICD SWITCHED TO MONITOR ONLY MODE FROM EXPOSURE TO A MAGNETIC FIELD. 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 64 YR Other THE DEVICE 0041/761393 WAS IMPLANTED 14-AUG-1987| THE DEVICE 0030/072207 WAS IMPLANTED 14-AUG-1987| THE DEVICE 0030/016260 WAS IMPLANTED 14-AUG-1987| THE DEVICE 0041/761394 WAS IMPLANTED 14-AUG-1987