BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 2031951 · Received March 11, 2011

    Report

    Report Number
    2031951
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    December 16, 2010
    Report Date
    March 3, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BROUGHT TO THE ED BY AMBULANCE, FROM A SKILLED NURSING FACILITY, AFTER THE DEVICE FIRED MULTIPLE TIMES. THE PATIENT DID NOT EXPERIENCE CHEST PAIN PRIOR TO FIRING. THE DEVICE FIRED AGAIN AFTER ADMISSION TO THE ED. PACING WAS TURNED OFF IN THE ED AND MONITOR MODE MAINTAINED ENABLED. THE CAUSE OF THE SHOCKS WAS DETERMINED TO BE A SPRINT FIDELIS LEAD FRACTURE. THE PATIENT WAS DOCUMENTED AS HAVING A LIFE EXPECTANCY OF GREATER THAN 1 YEAR, IF NOT LONGER. THE PATIENT WAS SCHEDULED FOR LEAD REVISION AND ICD GENERATOR CHANGE, AS DEVICE WAS AT MIDDLE-OF-LIFE (MOL) 2, AND LIKELY HAD LESS THAN 1 YEAR LEFT. THE PATIENT HAD A SATISFACTORY OUTCOME.====================== MANUFACTURER RESPONSE FOR LEAD, SPRINT FIDELIS LEAD======================NO RESPONSE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR