BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 2051929 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05686
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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 6949 LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD "SWEATING, PAIN UNDER LEFT ARMPIT, AND HEART BEATING LIKE CRAZY" AND THAT THE PATIENT HAD NOT SEE A PHYSICIAN IN A LONG TIME. ACCORDING TO THE PATIENT, AN X-RAY PERFORMED A FEW MONTHS AGO SHOWED A "LEAD WIRE OUT OF POSITION". FROM FOLLOW-UP WITH THE PATIENT'S PHYSICIAN, IT WAS DETERMINED THAT THE PATIENT HAD NOT BEEN IN THE OFFICE SINCE 2009. THE SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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 71 YR Other