BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX S 65

    MDR report key: 2213010 · Received August 9, 2011

    Report

    Report Number
    1028232-2011-01774
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(4) MDR - AFTER AN IMPLANT DURATION OF 12 DAYS, THIS LEAD WAS EXPLANTED DUE TO PERICARDIAL TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization