BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 69128 · Received January 9, 1997

    Report

    Report Number
    2124215-1997-00288
    Event Type
    Malfunction
    Date Received
    January 9, 1997
    Date of Event
    September 17, 1996
    Report Date
    September 17, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    N030/031-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 TO BE IN MONITOR ONLY MODE (THE ICD WILL MONITOR ARRHYTHMIAS BUT WILL NOT DELIVER THERAPY) AT A ROUTINE FOLLOW-UP EXAMINATION. THIS SAME ICD HAD BEEN FOUND IN MONITOR ONLY IN SEPTEMBER OF 1995; THIS EVENT WAS NOT PREVIOUSLY REPORTED TO CPI. 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 68 YR Other THE DEVICE 0041/224516 WAS IMPLANTED 02-MAR-1994| THE DEVICE 0010/007289 WAS IMPLANTED 02-MAR-1994| THE DEVICE 0041/224327 WAS IMPLANTED 02-MAR-1994