BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3152770 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05685
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CONCOMITANT PRODUCTS: 389066 COMPETITOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2007, WG124965 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHECK AN EPISODE OF NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE EVENT MAY HAVE BEEN PREMATURE VENTRICULAR CONTRACTIONS OR T-WAVE OVERSENSING (TWOS). THE NOISE WAS NOT ABLE TO BE REPLICATED, AND IMPEDANCE, THRESHOLD, AND SENSING WERE STABLE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257455 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR