BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 73779 · Received January 16, 1997

    Report

    Report Number
    2124215-1997-00585
    Event Type
    Malfunction
    Date Received
    January 16, 1997
    Date of Event
    October 31, 1996
    Report Date
    November 1, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    N030/031-5
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS PATIENT WAS BROUGHT TO THE EMERGENCY ROOM IN VENTRICULAR TACHYCARDIA, AND THE IMPLANTED VENTAK PRX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND IN MONITOR ONLY MODE (DEVICE CAN SENSE ARRHYTHMIAS BUT WILL NOT DELIVER THERAPY). FURTHER REVIEW OF THE PATIENT'S RECORD SHOWS THAT THE ICD WAS IN MONITOR ONLY MODE AT THE PREVIOUS FOLLOW-UP IN SEPTEMBER, BUT WAS NOT RE-PROGRAMMED AT THAT TIME. THE FOLLOW-UP FOR MAY SHOWS THE ICD WAS IN MONITOR+THERAPY MODE WHEN THE PATIENT LEFT THE CLINIC. 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 (>10GAUSS) MAGNETIC FIELDS.' THIS ICD FALLS UNDER FDA SAFETY ALERT FDA#N030/031-5. THE PHYSICAN 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 65 YR Other THE DEVICE 0074/003296 WAS IMPLANTED 17-OCT-1994