BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 1162256 · Received September 4, 2008

    Report

    Report Number
    1028232-2008-01078
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    June 18, 2008
    Report Date
    August 8, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE ANALYSIS CHECKED THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD. THERE WERE NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR. SENSING PROBLEMS AND INADEQUATE SHOCK DELIVERIES WERE REPORTED AFTER AN IMPLANTATION TIME OF 7 DAYS. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK GMBH AND CO 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization