BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2020892 · Received March 16, 2011

    Report

    Report Number
    2182208-2011-00430
    Event Type
    Death
    Date Received
    March 16, 2011
    Manufacturer
    MEDTRONIC, 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
    MO, 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 PATIENT IS INVOLVED IN A SETTLEMENT INVOLVING THE SPRINT FIDELIS LEADS. THE ACTUAL MODEL AND SERIAL NUMBER (MANUFACTURING DATE) ASSOCIATED WITH THE PATIENT IS UNKNOWN. HOWEVER MODEL NUMBER 6949 IS BEING ASSOCIATED WITH THIS EVENT. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT "RECEIVED A DEFECTIVE LEAD" AND PATIENT HAD "PAIN AND DISCOMFORT AND REQUIRING INCREASED MEDICAL MONITORING AND ADJUSTMENT". THE PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, AND ECONOMIC LOSSES AND CONSEQUENTIAL DAMAGES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death