BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/16

    MDR report key: 1984483 · Received February 1, 2011

    Report

    Report Number
    1028232-2011-00231
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 24, 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

    BOTH THE RV AND RA WERE NOT IMPLANTED. THE RV LEAD HAD BEEN PLACED AND THE RA LEAD WAS IN THE PROCESS OF BEING PLACED, WHEN THE PATIENT CODED DUE TO CARDIAC TAMPONADE. THE PHYSICIAN DECIDED TO WAIT UNTIL THE PATIENT WAS MORE STABLE TO TRY IMPLANTING AGAIN. BOTH LEADS WERE DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT 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 78 YR Hospitalization