BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 65/16

    MDR report key: 2822044 · Received October 9, 2012

    Report

    Report Number
    1028232-2012-02502
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    August 9, 2012
    Report Date
    September 27, 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, OVERSENSING ON THE VENTRICLE CHANNEL WAS REPORTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE DEVICE WAS EXPLANTED.

    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 Hospitalization