BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2951938 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00285
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P010015/S012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANTS: 5076-45 IMPLANTABLE PACING LEAD: (B)(6) 2001; 5076-52 IMPLANTABLE PACING LEAD: (B)(6) 2001; 2187-75 IMPLANTABLE PACING LEAD: (B)(6) 2001. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD WAS NOT CAPTURING AND THERE WAS HIGH IMPEDANCE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD THRESHOLD WAS HIGH, THERE WAS OVERSENSING AND ELEVATED IMPEDANCE. SETTING ADJUSTMENTS WERE MADE AND THE LEADS REMAIN 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
    57293 SPRINT FIDELIS ELECTRODE, PACEMAKER, PERMANENT LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention BIVENTRICULAR DEFIBRILLATOR