BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 578369 · Received March 4, 2005

    Report

    Report Number
    2938836-2005-00081
    Event Type
    Injury
    Date Received
    March 4, 2005
    Date of Event
    February 10, 2005
    Report Date
    February 10, 2005
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ST. JUDE MEDICAL REP PHONED TECHNICAL SERVICES TO REPORT THAT THE ICD COULD NOT BE INTERROGATED. AFTER REBOOTING THE PROGRAMMER, INTERROGATION WAS SUCCESSFUL, BUT IT WAS NOTED THAT REAL TIME GMD'S WERE NOT PRESENT AND THE DEVICE WAS IN THE SOFTWARE RESET PARAMETERS. THE ICD COULD NOT BE PROGRAMMED IT WAS RECOMMENDED THAT THE DEVICE BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. CRMD V-240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other