BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2337450 · Received November 15, 2011

    Report

    Report Number
    2182208-2011-02906
    Event Type
    Injury
    Date Received
    November 15, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0068-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA 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. TUZCU, "RESOLUTION OF T-WAVE OVERSENSING WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR GENERATOR REPLACEMENT IN AN ADOLESCENT ", PACE; 2007:30:929-932.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA SCIENTIFIC LITERATURE THAT THE PATIENT RECEIVED FOUR INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING (TWOS). THE PATIENT'S DAILY DOSE OF ATENOLOL HAD BEEN INCREASED, WITH NO SUCCESS IN PREVENTING THE SHOCKS. FOLLOW-UP WAS ATTEMPTED TWICE TO GATHER ADDITIONAL DETAIL, BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD REMAINS IN USE. 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 16 YR Hospitalization| L| O| R