BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1862576 · Received October 8, 2010

    Report

    Report Number
    2182208-2010-00710
    Event Type
    Injury
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. EVALUATION SUMMARY: 6949 LEAD: A PARTIAL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE DISTAL CONDUCTOR WAS FRACTURED (FLEXED, CLAVICLE-RIB). BLOOD WAS PRESENT IN/ON THE HELIX MECHANISM AND THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL. IT WAS ALSO NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED, THE DEFIBRILLATION COIL WAS DISTORTED, SEVERAL CONDUCTORS WERE DISTORTED, THE OUTER INSULATION WAS BREACHED, THE OUTER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING WAS BREACHED AND TORN.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other