BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTON DR DUAL-CHAMBER DEFIBRILLATOR

    MDR report key: 724970 · Received June 8, 2006

    Report

    Report Number
    2938836-2006-00438
    Event Type
    Injury
    Date Received
    June 8, 2006
    Date of Event
    May 23, 2006
    Report Date
    May 23, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY ST. JUDE MEDICAL, INC., CRMD

    Description of Event or Problem · 1

    THE ST. JUDE MEDICAL REPRESENTATIVE PHONED TO REPORT THAT UPON INITIAL INTERROGATION THE DEVICE WAS FOUND IN HWVVI RESET. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND PLACED ON EXTERNAL MONITORING. ONCE THE PATIENT STABILIZED, THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTON DR DUAL-CHAMBER DEFIBRILLATOR IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-230HV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Hospitalization| R