BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 1791320 · Received August 10, 2010

    Report

    Report Number
    2182208-2010-00430
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    February 19, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. CORRECTED DEVICE MODEL AND SERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEFT VENTRICULAR LEAD IMPEDANCE WAS GREATER THAN 2500 OHMS. FOLLOW-UP ATTEMPTS WERE UNABLE TO CONFIRM THE STATUS OF THE PATIENT AND THE LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. UPON FURTHER REVIEW, IT WAS DETERMINED THAT "LV" MEANT LOW VOLTAGE, OR PACING IMPEDANCE. TO DATE, NO NEW INFORMATION HAS BEEN OBTAINED REGARDING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other