BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 2891667 · Received November 21, 2012

    Report

    Report Number
    1028232-2012-02940
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 8, 2012
    Report Date
    November 8, 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

    THERE WAS NOISE ON THE RV CHANNEL. THE PHYSICIAN ATTEMPTED TO EXTRACT THIS LEAD BUT WAS UNABLE TO REMOVE IT DUE TO STENOSIS. THE LEAD WAS CAPPED AND REPLACED. SHOULD ADD'L INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization