BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINOX SD 65/18

    MDR report key: 2213108 · Received August 9, 2011

    Report

    Report Number
    1028232-2011-01799
    Event Type
    Death
    Date Received
    August 9, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT EXPIRED SHORTLY AFTER IMPLANT DURING HIS FIRST DIALYSIS PROCEDURE. INITIAL INTERROGATION OF THE DEVICE SHOWS NO ARRHYTHMIA DETECTIONS OR RECORDINGS RELATED TO THE PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death