BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 487544 · Received July 10, 2003

    Report

    Report Number
    2182208-2003-00223
    Event Type
    Injury
    Date Received
    July 10, 2003
    Date of Event
    May 14, 2003
    Manufacturer
    MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    INAPPROP SHOCKS, IMPEDANCE > 2000, NO PACING AT MAX OUTPUT, NOISE SEEN ON V-TIP/V-RING EGM, FRACTURED CONDUCTOR SUSPECTED THEREFORE LEAD REPLACEMENT IS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION 6945 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other 7227CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB