BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2954417 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02303
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 14, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALARM WAS TRIGGERED. UPON REVIEW OF THE REMOTE MONITORING TRANSMISSION IT WAS NOTED THAT THE V-V COUNT INDICATED A POTENTIAL LEAD INSULATION DEFECT. MANY NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVTS) CAUSED BY NOISE WERE DETECTED, A LEAD CONDUCTOR FRACTURE WAS CONFIRMED, AND THERE WAS OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS REPLACED.IT WAS ALSO NOTED THAT THE PATIENT WAS ENROLLED IN THE SYSTEM LONGEVITY STUDY (SLS). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED ASA RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58013 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694865

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R