BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 749153 · Received August 9, 2006

    Report

    Report Number
    2124215-2006-16644
    Event Type
    Injury
    Date Received
    August 9, 2006
    Date of Event
    June 30, 2006
    Report Date
    June 30, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD (222340) DISLODGED ONE DAY AFTER IMPLANT AND WAS UNABLE TO BE REPOSITIONED BECAUSE THE HELIX MECHANISM WOULD NOT RETRACT. A NEW LEAD (220124) WAS ATTEMPTED, BUT WAS ELECTIVELY REMOVED AND REPLACED DUE TO DRIED BLOOD ON THE HELIX MECHANISM. A THIRD LEAD WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4088 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention