BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINOX SD 65/18

    MDR report key: 1661285 · Received April 13, 2010

    Report

    Report Number
    1028232-2010-00660
    Event Type
    Death
    Date Received
    April 13, 2010
    Date of Event
    August 25, 2009
    Report Date
    March 9, 2010
    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

    THE ANALYSIS CHECKED THE PROPERTIES OF THE LEAD. THERE WERE NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THE CUTS IN THE OUTER INSULATION AND THE DEFORMATION OF THE OUTER CONDUCTOR HELIX ARE PROBABLY DUE TO THE EXPLANTATION PROCESS. THE ANALYSIS DID NOT FIND A MANUFACTURING ERROR OR MATERIAL DEFECT ON EITHER THE LEAD OR THE ICD.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 5 MONTHS, THE PATIENT ARRIVED AT THE FOLLOW-UP WITH EPISODES OF VT AND SHOCK. THE DEVICE HAD WORKED WITHOUT PROBLEMS. AN INCREASE IN PACING THRESHOLD WAS NOTED AND THE PATIENT WAS SUPPOSE TO COME TO THE NEXT FOLLOW-UP IN 4 WEEKS, IN ORDER TO CONTROL THE PACING THRESHOLD INCREASE. ON (B) (6) 2009, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM CLOSE TO DEATH AND DIED. THE ICD COULD NOT BE INTERROGATED. LUMOS VR-T, (B) (4) 1028232-2010-00659.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death