BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 2143178 · Received June 16, 2011

    Report

    Report Number
    2143178
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    February 24, 2011
    Report Date
    May 2, 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

    PATIENT PRESENTED TO THE ED YESTERDAY WITH A CHIEF COMPLAINT OF RECEIVING A SINGLE SHOCK FROM HER AICD IN THE MORNING WHILE AT REST. SHE ALSO COMPLAINED OF LEFT-SIDED CHEST PAIN. THE EP NP WAS CALLED TO CONSULT. "INTERROGATION OF THE DEFIBRILLATOR REVEALED HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) WIRE, WHICH IS INDICATIVE OF A FIDELIS LEAD FRACTURE. THE DEVICE WAS DEACTIVATED TO PREVENT ANY FURTHER INAPPROPRIATE SHOCKS AND EXTERNAL DEFIBRILLATOR PADS WERE PLACED. SHE WILL UNDERGO AN RV WIRE REVISION AND LIKELY GENERATOR CHANGE." THE LEAD WAS CAPPED AND REMAINS INSITU. THE PATIENT'S OUTCOME WAS SATISFACTORY AND SHE WAS DISCHARGED TO HOME. ====================== MANUFACTURER RESPONSE FOR LEAD, SPRINT FIDELIS (PER SITE REPORTER)======================MANUFACTURER HAS RECALLED THIS PRODUCT, AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD, DEFIBRILLATION LWS MEDTRONIC, INC. 6949-58 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR