BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAF-D-FIB

    MDR report key: 17468 · Received October 5, 1994

    Report

    Report Number
    17468
    Event Type
    Injury
    Date Received
    October 5, 1994
    Date of Event
    May 29, 1994
    Report Date
    June 9, 1994
    Manufacturer
    MEDTRONIC
    Product Code
    DRK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIAC ARREST, WHILE PATIENT IN PULSELESS VENTRICULAR TACHYCARDIA, AN ATTEMPT WAS MADE TO DEFIBRILLATE THE PATIENT. THE DEFIBRILLATOR PADS WERE APPLIED TO THE PATIENT. A LIFEPACK WAS USED TO DEFIBRILLATE PATIENT. THE DEFIBRILLATOR DISCHARGED BUT THERE WAS NO EVIDENCE THAT THE SHOCK WENT THROUGH TO THE PATIENT.A SECOND LIFEPACK WAS THEN USED WITH THE SAME DEFIBRILLATOR PADS. THE DEFIBRILLATOR DISCHARGED BUT AGAIN THERE WAS NO EVIDENCE THAT THE SHOCK WENT THROUGH TO THE PATIENT. THE DEFIBRILLATOR PADS WERE THEN REMOVED AND PADS MANUFACTURED BY A DIFFERENT COMPANY WERE APPLIED. THE PATIENT WAS THEN ABLE TO BE DEFIBRILLATED. THERE WERE NO MARKINGS OR BURNS NOTED AT THE DEFIBRILLATOR PAD SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-D-FIB DEFIBRILLATOR PAD DRK MEDTRONIC 1220-002 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 * Life Threatening TWO (2) PHYSIO-CONTROL LIFEPACK(S)