BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2083046 · Received May 10, 2011

    Report

    Report Number
    2649622-2011-07472
    Event Type
    Death
    Date Received
    May 10, 2011
    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
    OH, US
    Reporter Occupation
    ATTORNEY

    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. PER LEGAL ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT AND NO FURTHER INFORMATION IS AVAILABLE. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT DIED APPROXIMATELY 15 MONTHS POST IMPLANT OF THE RIGHT VENTRICULAR LEAD. IT WAS ALSO NOTED THE PATIENT SUFFERED EXTREME PHYSICAL INJURY.

    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 66 YR Death| O (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| COMPETITOR IMPLANTABLE PACING LEAD