BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 2964762 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02159
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH THE PERFORMANCE AND FAILURE RATE OF THE DEFECTIVE LEAD. FOLLOW-UP ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE CLINIC ARE IN PROGRESS, BUT NO INFORMATION WAS RECEIVED AT THE TIME OF THIS REPORT. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION WAS RECEIVED FROM THE CLINIC WHICH DISCLOSED THAT THE LEAD WAS FOUND TO BE FUNCTIONING NORMALLY AND THERE ARE NO ALLEGATIONS AGAINST PERFORMANCE OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68846 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR D154VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR