BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL-S 65/16 STEROID

    MDR report key: 1913418 · Received November 24, 2010

    Report

    Report Number
    1028232-2010-02574
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 11, 2010
    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 DEVICE WAS RETURNED WITH (B)(4) DOCUMENTATION FROM (B)(4). PER (B)(4), THIS DEVICE WAS REMOVED DUE TO INAPPROPRIATE SHOCKS. THE LEAD APPEARS TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX SL-S 65/16 STEROID ICD LEAD LWS BIOTRONIK SE & CO. KG 345988

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization