BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2021224 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-04084
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    November 10, 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
    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 DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES AS A RESULT OF THE LEAD, PATIENT "HAS SUSTAINED SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES" AND "SUFFERED BODILY INJURY AND RESULTING PAIN AND SUFFERING, DISABILITY, DISFIGUREMENT, MENTAL ANGUISH, LOSS OF CAPACITY OF THE ENJOYMENT OF LIFE, SHORTENED LIFE EXPECTANCY, AND EXPENSES OF HOSPITALIZATION, MEDICAL AND NURSING CARE AND TREATMENT, MONITORING, AND LOSS OF EARNINGS AS WELL AS LOSS OF ABILITY TO EARN MONEY AND OTHER ECONOMIC DAMAGES PRIOR TO (PATIENT'S) DEATH. (PATIENT) DIED AS A DIRECT AND PROXIMATE RESULT OF DEFECTS IN DEFENDANTS' SPRINT FIDELIS 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 46 YR Death 7235CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB