BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3151637 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05676
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES. THE FULL LEAD IN SEGMENTS WAS SUBSEQUENTLY RETURNED AND ANALYZED. THE DEFIBRILLATION CONDUCTOR WAS FRACTURED/FLEXED AND THE DISTAL CONDUCTOR WAS DISTORTED DUE TO OVER ROTATION. IT WAS NOTED THAT THE DISTAL ELECTRODE WAS COVERED WITH BODY TISSUE/FIBROTIC GROWTH. CONCOMITANT MEDICAL PRODUCT: 7231CX, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING (TWOS) ON RIGHT VENTRICULAR (RV) LEAD. THE LEAD ALSO HAD AN INCREASED V-V INTERNAL COUNT. THE LEAD WAS EXPLANTED AND 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
    253132 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693165

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| L| R