BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTON MICRO DR CARDIOVERTER DEFIBRILLATOR SYSTEM

    MDR report key: 462909 · Received May 28, 2003

    Report

    Report Number
    2938836-2003-00221
    Event Type
    Injury
    Date Received
    May 28, 2003
    Date of Event
    April 28, 2003
    Report Date
    April 28, 2003
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ICD WAS IMPLANTED BY THE PHYSICIAN WITHOUT THE PRESENCE OF A FIELD CLINICAL ENGINEER (FCE) IN 2003. THE PHYSICAN HAD PROGRAMMED THE DEVICE TO ONLY BRADY SUPPORT. TWO DAYS LATER, THE FCE WAS CALLED TO TURN ON THE DEVICE AND TO TEST FV INDUCTION. THE MEASURED DATE WAS FOUND TO BE IN DEFIB OFF AND THE BRADY SUPPORT PROGRAMMED BY THE PHYSICIAN. THE LIFETIME DIAGNOSTICS SHOWED DEVICE CHARGING HISTORY VALUES. THE PHYSICIAN CONFIRMED THAT WHEN THE DEVICE WAS INTERROGATED AT IMPLANT HE OBSERVED IN THE SUMMARY, DEFIB OFF BUT DID NOT TAKE A LOOK AT THE LIFETIME DIAGNOSTICS. THE DECISION WAS MADE TO EXPLANT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTON MICRO DR CARDIOVERTER DEFIBRILLATOR SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM LWS ST. JUDE MEDICAL, INC., CRMD V-232 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other THERAPY DATES: NA.