BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2032981 · Received March 29, 2011

    Report

    Report Number
    2649622-2011-04285
    Event Type
    Death
    Date Received
    March 29, 2011
    Date of Event
    August 3, 2007
    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
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE PATIENT IS INVOLVED IN A SETTLEMENT INVOLVING THE SPRINT FIDELIS LEADS. 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

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE LEAD HAD EXHIBITED A FRACTURE AND/OR WAS EXPLANTED. ADDITIONALLY IT WAS ALLEGED THE PATIENT EXPERIENCED COMPLICATIONS. INFORMATION IDENTIFIED IN THE MANUFACTURE DATABASE NOTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY EIGHT MONTHS POST IMPLANT OF THEIR BI-VENTRICULAR DEFIBRILLATOR AND LEAD.

    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 83 YR Death 4542 COMPETITOR IMPLANTABLE PACING LEAD