BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2063519 · Received April 19, 2011

    Report

    Report Number
    2649622-2011-07221
    Event Type
    Death
    Date Received
    April 19, 2011
    Date of Event
    March 22, 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
    MS, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION OBTAINED INDICATED THE PATIENT HAD BEEN HOSPITALIZED SIX WEEKS PRIOR TO DEATH DUE TO CHEST PAIN AND RECEIVING THERAPY. INTERROGATION REPORT INDICATES THE PATIENT HAD AN APPROPRIATE SHOCK FOR VENTRICULAR TACHYCARDIA. THE PATIENT WAS DISCHARGED AT THAT TIME WITH HOME HEALTH CARE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S FAMILY THAT THE PATIENT HAD PASSED AWAY AND THAT THE "DEFIBRILLATOR DIDN'T GO OFF." ALSO REPORTED THAT THE PATIENT HAD BEEN IN THE HOSPITAL "FOR FLUID ON" THE PATIENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 50 YR Death| H| L