BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL 65/16 STEROID

    MDR report key: 1942218 · Received December 22, 2010

    Report

    Report Number
    1028232-2010-02842
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    September 29, 2010
    Report Date
    December 13, 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 LEAD WAS EXPLANTED DUE TO INCREASED THRESHOLDS WHILE UPGRADING THE PT TO A DUAL CHAMBER ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX SL 65/16 STEROID ICD LEAD LWS BIOTRONIK SE & CO. KG 347351

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization