BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3160499 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08034
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: H170 COMPETITOR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR 2005 (B)(6); 4542 COMPETITOR IMPLANTABLE PACING LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE HAD GRADUALLY INCREASED AND WAS NOW MEASURING HIGH. IT WAS ALSO REPORTED THAT THERE WAS A RISE IN THE RV LEAD THRESHOLD. THE RV LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259728 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R (B)(4) COMPETITOR IMPLANTABLE PACING LEAD