BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATOS LV

    MDR report key: 2151392 · Received June 8, 2011

    Report

    Report Number
    1028232-2011-01242
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE REPORTS ERRONEOUS OUT OF RANGE PACING IMPEDANCE VALUES IN THE RIGHT ATRIAL AND RIGHT VENTRICULAR CHANNELS THAT CANNOT BE DUPLICATED THROUGH PSA OR ANOTHER DEVICE. NO ADVERSE EVENTS ARE REPORTED FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATOS LV CRT PACEMAKER NKE BIOTRONIK SE & CO. KG 338200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization