BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3071714 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05210
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT: D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT FOR A STEADY AND GRADUAL RISE OF IMPEDANCE. THEN, SUBSEQUENTLY, HIGH IMPEDANCE WAS MEASURED. 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
    172135 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR