BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/16

    MDR report key: 840961 · Received April 20, 2007

    Report

    Report Number
    1028232-2007-00140
    Event Type
    Injury
    Date Received
    April 20, 2007
    Date of Event
    January 14, 2007
    Report Date
    April 11, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER STUDY CRF "ICD EXPLANTED DUE TO SEPTIC SHOCK". ALSO EXPLANTED WAS A LUMOS DR-T, MDR 1028232-07-0139.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization