BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3992976 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09565
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S 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 THERE WAS T-WAVE OVERSENSING (TWOS) OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. R WAVES HAD CONSISTENTLY BEEN AROUND 10MV UNTIL A COUPLE OF MONTHS AGO WHEN THEY DROPPED SUDDENLY TO 1-1.5MV. YESTERDAY THERE WAS NO SENSING WHEN CONDUCTING A SENSING TEST AT A NON PROGRAMMABLE SENSITIVITY OF 1.2MV AND THE MEASURED R WAVE ON PAPER WAS AROUND 1.5MV. GIVEN THE SUDDEN DROP IN R WAVE AMPLITUDE, POSSIBLY DUE TO THE TWOS, AND THE POTENTIAL FOR LEAD INSULATION BREACH, THE PHYSICIAN IS CONSIDERING A LEAD REPLACEMENT DURING THE DEVICE CHANGE OUT PROCEDURE THAT IS SCHEDULED FOR NEXT WEEK. 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
    467755 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D154ATG ICD