BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1994148 · Received February 16, 2011

    Report

    Report Number
    2649622-2011-03042
    Event Type
    Death
    Date Received
    February 16, 2011
    Date of Event
    September 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVES A LEGAL CASE IN PROGRESS OR POTENTIAL LITIGATION. THE PROPRIETARY NATURE OF THE EVENT MAY AFFECT FOLLOW UP EFFORTS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. WE HAVE NO INFORMATION FROM A HEALTH CARE PROFESSIONAL TO SUGGEST THE DEATH WAS DEVICE RELATED. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM. THE CAUSE OF DEATH HAS BEEN RESEARCHED, BUT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES PATIENT WAS IMPLANTED WITH A 6949 LEAD AND AS A DIRECT AND PROXIMATE RESULT, PATIENT "SUFFERS FROM APPREHENSION AND FEAR THAT THE SPRINT FIDELIS LEAD IMPLANTED IN HIS HEART MAY FRACTURE, CAUSE INAPPROPRIATE SHOCKS, AND MAY FAIL TO PROVIDE SHOCKS NECESSARY TO MAINTAIN A REGULAR HEART RHYTHM OR REGULATE HIS HEART RATE, WHICH MAY LEAD TO SEVERE INJURY AND WHICH MAY BE FATAL. (PATIENT) HAS SUSTAINED EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES." REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH IS BEING REQUESTED.

    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 79 YR Death