BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 65/18

    MDR report key: 2882167 · Received November 13, 2012

    Report

    Report Number
    1028232-2012-02805
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR

    Description of Event or Problem · 1

    OUS MDR- AFTER AN UNKNOWN IMPLANT DURATION LOSS OF CAPTURE WAS REPORTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD AND THE ICD WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 359067

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization