BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 1932639 · Received November 23, 2010

    Report

    Report Number
    1932639
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 21, 2010
    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'S DEFIBRILLATOR WAS CHECKED USING THE MEDTRONIC CARELINK NETWORK REMOTE FOLLOW-UP SERVICE. A RED ALERT WAS TRANSMITTED THAT THE SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION IMPEDANCE WAS ELEVATED. THE RV DEFIBRILLATION IMPEDANCE WAS 112 OHMS, WHICH INDICATED A COIL FRACTURE. THE PATIENT WAS NOTIFIED OF THIS OCCURRENCE BY PHONE AND PRESENTED TO THE DEVICE CLINIC THAT DAY. THE PATIENT WAS SEEN BY THE PHYSICIAN AND WAS ADMITTED TO THE CARDIAC SHORT STAY UNIT (CSSU). THE LEAD WAS CAPPED, REMAINS INSITU AND THERE WAS AN IMPLANT OF A NEW RV LEAD AND ICD GENERATOR CHANGE. THE PATIENT'S OUTCOME WAS SATISFACTORY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE LEAD NEEDED TO BE REPLACED BY ANOTHER AND THIS REQUIRED A SEPARATE PROCEDURE.====================== MANUFACTURER RESPONSE FOR LEAD, SPRINT FIDELIS======================NO RESPONSE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD, DEFIBRILLATION LWS MEDTRONIC, INC. 6949-65CM *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR