BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 2891755 · Received November 21, 2012

    Report

    Report Number
    1028232-2012-02907
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    June 28, 2012
    Report Date
    November 12, 2012
    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

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 18 MONTHS, OVERSENSING WAS REPORTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE DEVICE IS UNDER ANALYSIS AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization