BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2072247 · Received April 28, 2011

    Report

    Report Number
    2649622-2011-07363
    Event Type
    Death
    Date Received
    April 28, 2011
    Date of Event
    February 26, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. 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 "MALFUNCTIONED AND INAPPROPRIATELY FIRED IN EXCESS OF 30 TIMES. DECEDENT WAS RUSHED TO THE HOSPITAL FOR EMERGENT CARE BUT DIED SHORTLY AFTER REACHING THE HOSPITAL." THE PATIENT "HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES, AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES FOR WHICH" THE PATIENT "IS ENTITLED TO COMPENSATORY AND EQUITABLE DAMAGES AND DECLARATORY RELIEF IN AN AMOUNT TO BE PROVEN AT TRIAL."

    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 73 YR Death| H| L| R 5076-1 IMPLANTABLE PACING LEAD| 5076-2 IMPLANTABLE PACING LEAD