BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2955398 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01480
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 10, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: 4193 IMPLANTABLE PACING LEAD 2005 (B)(6); (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 2010 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR AND LEFT VENTRICULAR LEADS HAD HIGH PACING THRESHOLDS. THE RIGHT VENTRICULAR PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED, AND THE HIGH VOLTAGE PORTION REMAINS IN USE. THE LEFT VENTRICULAR LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58517 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD