BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 486092 · Received September 16, 2003

    Report

    Report Number
    3015876-2003-00368
    Event Type
    Malfunction
    Date Received
    September 16, 2003
    Date of Event
    August 17, 2003
    Report Date
    August 19, 2003
    Manufacturer
    MEDTRONIC PHYSIO-CONTROL CORP.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS BEING USED TO ADMINISTER PACING THERAPY TO THE PATIENT. REPORTEDLY, COINCIDENTLY WITH DISHCARGE OF AN INTERNAL CARDIAC DEFIBRILLATOR (ICD) TO THE PATIENT, THE DEVICE PACING CURRENT DROPPED TO 0MA, WITH NO ALARMS OBSERVED. THIS WAS SAID TO HAVE OCCURRED MORE THAN ONCE WHILE THE PATIENT WAS BEING TREATED. THE EXTERNAL DEFIBRILLATOR WAS USED TO SUCCESSFULLY CONVERT THE PATIENT TO A VIABLE RHYTHM. THE REPORTER STATED THAT THERE WERE NO ADVERSE AFFECTS TO THE PATIENT REPORTED BY THE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR LDD MEDTRONIC PHYSIO-CONTROL CORP. 9P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INTERNAL CARDIAC DEFIBRILLATOR (ICD).