BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 60/16

    MDR report key: 1780857 · Received July 29, 2010

    Report

    Report Number
    1028232-2010-01689
    Event Type
    Injury
    Date Received
    July 29, 2010
    Date of Event
    June 17, 2010
    Report Date
    July 14, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS LEAD WAS EXPLANTED DUE TO TWIDDLER'S SYNDROME AND REPLACED WITH A LINOX SD 65/16, (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 60/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 363303

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization