BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S 65

    MDR report key: 2883813 · Received November 16, 2012

    Report

    Report Number
    1028232-2012-02751
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    September 5, 2012
    Report Date
    October 23, 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 IMPLANTATION TIME OF 11 MONTHS, INCORRECT DETECTIONS WERE OBSERVED. A LEAD DEFECT WAS SUSPECTED. NO DETERIORATION IN THE PATIENT'S STATE OF HEALTH WAS REPORTED. THE LEAD WAS EXPLANTED AND A NEW ONE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 369818

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization