BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 2891668 · Received November 21, 2012

    Report

    Report Number
    1028232-2012-02953
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOISE FROM AN INSULATION BREAK WAS SEEN ON A SURFACE AND INTRACARDIAC RECORDING AND WAS CORROBORATED VIA DECREASING PACE/SENSE IMPEDANCE VALUES. THE LEAD WILL BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other