BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFILE MD V-186 SERIES TIERRED THERAPY DEFIB.

    MDR report key: 479453 · Received August 22, 2003

    Report

    Report Number
    2938836-2003-00369
    Event Type
    Injury
    Date Received
    August 22, 2003
    Date of Event
    July 23, 2003
    Report Date
    July 23, 2003
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ICD HAS REACHED ERI, 29 MONTHS POST-IMPLANT. IT WAS ALSO NOTED THAT A DEVICE PARAMETER ERROR MESSAGE HAD BEEN DETECTED. THE DEVICE CONFIGURATION WAS SET ON N/A AND ALL FUNCTIONS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE MD V-186 SERIES TIERRED THERAPY DEFIB. IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-186HV3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other THERAPY DATES: NA.