BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 2953239 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00980
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    December 11, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BIPOLAR LEAD IMPEDANCE WARNING WAS TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPEDANCE HAD SLIGHT GRADUAL INCREASE FROM 750 OHMS TO 1000 OHMS. 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
    55993 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR 5076 IMPLANTABLE PACING LEAD