BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3740128 · Received April 10, 2014

    Report

    Report Number
    2649622-2014-02944
    Event Type
    Injury
    Date Received
    April 10, 2014
    Report Date
    January 13, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. CONCOMITANT PRODUCTS: 407645, IMPLANTABLE PACING LEAD, (B)(6) 2007; 419488, IMPLANTABLE PACING LEAD, (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY - DEFIBRILLATOR (CRT-D) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) EARL IER THAN EXPECTED BY THE CUSTOMER. IT WAS NOTED THAT THE RAPID DEPLETION WAS DUE TO HIGH OUTPUT SETTINGS FOR BOTH RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) CAPTURE. THE DEVICE WAS EXPLANTED AND REPLACED. THE RV LEAD WAS CAPPED AND REPLACED PROPHYLACTICALLY. THE LV 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
    219617 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR