BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 2844887 · Received November 2, 2012

    Report

    Report Number
    1028232-2012-02697
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    August 6, 2012
    Report Date
    October 23, 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

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF 41 MONTHS ARTIFACTS ON THE RIGHT VENTRICLE CHANNEL WERE REPORTED. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization