BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2061629 · Received April 18, 2011

    Report

    Report Number
    2649622-2011-07209
    Event Type
    Death
    Date Received
    April 18, 2011
    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 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

    A LAWSUIT ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A LEAD WIRE SYSTEM, AND SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD. THE PATIENT HAS SUFFERED REPEATED SHOCKS AND FRACTURES, AFTER THE ENHANCED MONITORING SYSTEM WAS IN PLACE, AND THE MONITORING FAILED. THE PATIENT SUFFERED THESE SHOCKS AND FRACTURES WITHOUT ANY ALARM SOUNDING FROM THIS PURPORTEDLY "ENHANCED" MONITOR. 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. INFORMATION IDENTIFIED IN THE MANUFACTURE DATABASE INDICATED THE PATIENT DIED APPROXIMATELY THREE YEARS AFTER IMPLANT OF THE LEAD AND SEVEN MONTHS PRIOR TO THE ALLEGATION.

    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 69 YR Death (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 3830 IMPLANTABLE PACING LEAD