BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2021118 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-04028
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    June 18, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE LEAD MODEL 6949 IS PART OF THE ADVISORY FOR THE MODEL.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT DIED APPROXIMATELY NINETEEN MONTHS POST IMPLANT OF THE RIGHT VENTRICULAR LEAD. IT WAS ALSO NOTED THE PATIENT SUFFERED SEVERE PHYSICAL INJURY. FURTHER REVIEW OF THE EVENT REVEALED THE PATIENT DIED APPROXIMATELY FIVE MONTHS POST IMPLANT OF IMPLANTABLE CARDIOVETER DEFIBRILLATOR AND LEADS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death