BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRX AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 95841 · Received May 8, 1997

    Report

    Report Number
    2124215-1997-01544
    Event Type
    Malfunction
    Date Received
    May 8, 1997
    Date of Event
    March 27, 1997
    Report Date
    March 27, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    N030/031-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT A PATIENT CAME IN TO THE CLINIC BECAUSE HER VENTAK PRX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS BEEPING. THE ICD WAS INTERROGATED AND FOUND TO BE IN MONITOR ONLY MODE (THE ICD MONITORS HEART ACTIVITY BUT DOES NOT DELIVER THERAPY) DUE TO THE PRESENCE OF A MAGNETIC FIELD. THE PATIENT REPORTED THAT NO MAGNETIC FIELD OR ELECTROMAGNETIC INTERFERENCE WAS PRESENT THAT SHE COULD IDENTIFY. 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 0041/225429 WAS IMPLANTED 23-MAY-1994| THE DEVICE 4261/210784 WAS IMPLANTED 04-MAY-1994| THE DEVICE 0940/758647 WAS IMPLANTED 04-MAY-1994| THE DEVICE 4269/206994 WAS IMPLANTED 04-MAY-1994| THE DEVICE 0041/224065 WAS IMPLANTED 23-MAY-1994| THE DEVICE 4320/019155 WAS IMPLANTED 23-MAY-1994| THE DEVICE 4320/020779 WAS IMPLANTED 23-MAY-1994