BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 1863008 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-11376
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS SET TO 0.3MV AT THE TIME OF THE T-WAVE OVERSENSING EPISODE NOTED IN THE FAXED REPORT. CALLER HAD A QUESTION ABOUT CHANGING THE SENSITIVITY TO ADDRESS THIS. THE DEVICE REMAINS IN USE. NO 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 52 YR Other 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB