BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL 65/18

    MDR report key: 2213860 · Received August 5, 2011

    Report

    Report Number
    1028232-2011-01763
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 15, 2010
    Report Date
    July 19, 2011
    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

    THIS LEAD WAS CAPPED DUE TO NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX SL 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 342396

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization