BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2790204 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14393
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT HAS BEEN HEARING ALERTS AND WAS TOLD THAT THE LEAD NEEDS TO BE REMOVED. FOLLOW UP NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAS BEEN ON THE RISE AND R-WAVE SENSITIVITY IS LOW AT TIMES. THE LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R H210 COMPETITOR IMPLANTABLE CARDIO/DEFIBRILLATOR