BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 65/18

    MDR report key: 2110381 · Received April 25, 2011

    Report

    Report Number
    1028232-2011-00933
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 26, 2011
    Report Date
    April 7, 2011
    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 IMPLANTATION TIME OF ABOUT 2 MONTHS, SHOCK DELIVERIES AFTER VENTRICULAR OVERSENSING WERE REPORTED. THE DEVICE WAS EXPLANTED.

    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