BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2131475 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00941
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. REFERENCED ARTICLE: "LONGEVITY OF SPRINT FIDELIS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEADS AND RISK FACTORS FOR FAILURE: IMPLICATIONS FOR PATIENT MANAGEMENT." CIRCULATION. FEBRUARY 1 2011;123(4):358-363.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING FAILURE MODES: LEAD FRACTURE OR "BREAKS IN THE HIGH-VOLTAGE CONDUCTOR," INFECTION, AND INAPPROPRIATE SHOCKS. THE LEADS WERE EXPLANTED/ABANDONED AND/OR REPLACED. NO FURTHER 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. 6931 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R