BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART SD 65/16

    MDR report key: 2062654 · Received April 11, 2011

    Report

    Report Number
    1028232-2011-00812
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 4, 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

    AFTER AN IMPLANT DURATION OF 4 WEEKS, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND HAD TO BE RESUSCITATED. BOTH ASSOCIATED LEADS WERE REPORTED TO BE DISLODGED. IT WAS REPORTED THAT THE PATIENT FULLY RECOVERED. THE ICD AND BOTH LEADS WERE NOT RETURNED TO BIOTRONIK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 359066

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other