BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 95722 · Received May 8, 1997

    Report

    Report Number
    2124215-1997-01425
    Event Type
    Malfunction
    Date Received
    May 8, 1997
    Date of Event
    March 12, 1997
    Report Date
    March 12, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    N030/031-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN MONITOR ONLY MODE (THERAPY DELIVERY DISABLED) WHEN INTERROGATED AT A NORMAL FOLLOW-UP VISIT. IN ADDITION IT WAS ALSO REPORTED THAT THE ICD WAS FOUND IN MONITOR ONLY MODE TWO YEARS PREVIOUS TO THIS EVENT. HOWEVER, IT WAS NEVER REPORTED TO CPI AT THAT TIME. NOTE: THE VENTAK 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 72 YR Other THE DEVICE 4312/045965 WAS IMPLANTED 21-MAR-1991| THE DEVICE 0041/135130 WAS IMPLANTED 21-MAR-1991| THE DEVICE 6836/000876 WAS IMPLANTED 14-MAR-1991| THE DEVICE 0041/133701 WAS IMPLANTED 21-MAR-1991| THE DEVICE 0041/135262 WAS IMPLANTED 21-MAR-1991| THE DEVICE 4312/045241 WAS IMPLANTED 21-MAR-1991