BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 60/16

    MDR report key: 2222405 · Received July 15, 2011

    Report

    Report Number
    1028232-2011-01572
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 13, 2011
    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 - ON (B)(6), HOME-MONITORING SYSTEM DETECTED NOISE ON THIS LEAD AND THIS LEAD WAS EXPLANTED. THE PHYSICIAN OBSERVED BLOOD INSIDE THE LEAD AND WHEN DISCONNECTED THEY ALSO FOUND 2 DEFORMED POINTS ABOUT 12.5CM AND 9.5CM FROM THE DISTAL TIP. THE PHYSICIAN SUSPECTS THE PENETRATED BLOOD MAY HAVE COME FROM THE DEFORMED AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART SD 60/16 ICD LEAD LWS BIOTRONIK SE & CO, KG 359065

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization