BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 69033 · Received January 9, 1997

    Report

    Report Number
    2124215-1997-00193
    Event Type
    Malfunction
    Date Received
    January 9, 1997
    Date of Event
    August 28, 1996
    Report Date
    August 29, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    N030/031-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS VENTAK PRX WAS FOUND IN MONITOR ONLY MODE (SENSING AND DETECTION FUNCTIONS WORKING BUT THERAPY DELIVERY INHIBITED) DURING DEVICE FOLLOW-UP. THE PATIENT REPORTED THAT HE WAS WORKING WITH POWER TOOLS THAT MAY HAVE CREATED A STRONG MAGNETIC FIELD. THE ICD WAS REPROGRAMMED TO MONITOR + THERAPY, AND THE ABILITY TO DEACTIVATE THE ICD THROUGH MAGNET APPLICATION WAS PROGRAMMED OFF AFTER THIS EVENT. 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 0048/001196 WAS IMPLANTED 21-JUL-1993| THE DEVICE 6836/006137 WAS IMPLANTED 21-JUL-1993| THE DEVICE 0074/001464 WAS IMPLANTED 21-JUL-1993