BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/16

    MDR report key: 1941869 · Received December 22, 2010

    Report

    Report Number
    1028232-2010-02823
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    April 13, 2010
    Report Date
    December 14, 2010
    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

    WHILE IMPLANTING THIS RV LEAD, THE PT DEVELOPED "UNSTABLE HEMODYNAMICS REQUIRING ACUTE PERICARDIOCENTESIS." FOLLOWING THE PROCEDURE, THE PT STABILIZED IMMEDIATELY AND THE SYS WAS SUCCESSFULLY IMPLANTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization