BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1013430 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00916
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    December 3, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    Removal / Correction Number
    Z-0067-007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 87 YR Required Intervention 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 1688TC IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD