BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 825926 · Received March 9, 2007

    Report

    Report Number
    2649622-2007-00567
    Event Type
    Injury
    Date Received
    March 9, 2007
    Date of Event
    December 28, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE VARIED FROM 700-1456 OHMS, AND THERE WAS AN APPARENT LEAD FRACTURE. IT WAS ALSO NOTED THAT THE PATIENT FELL. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other