BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/16

    MDR report key: 1012613 · Received March 10, 2008

    Report

    Report Number
    1028232-2008-00211
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    September 25, 2007
    Report Date
    February 8, 2008
    Manufacturer
    BIOTRONIK GMH AND CO
    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

    NO MATERIAL DEFECTS OR MFG ERRORS COULD BE DETERMINED DURING LEAD ANALYSIS. THE LEAD FIXATION WAS FOUND TO BECOME STUCK AND UNSTUCK DURING ANALYSIS. THIS OBSERVATION COULD BE TRACED BACK TO THE COAGULATED BLOOD AND TISSUE RESIDUE PRESENT IN THE SCREW TIP. OTHERWISE, NOTHING UNUSUAL COULD BE OBSERVED THAT WOULD BE RELATED TO THIS DISLOCATION OBSERVED AT THE CLINIC.

    Description of Event or Problem · 1

    THE LEAD WAS DISLOCATED. ATTEMPTS TO REPLACE, IT FAILED BECAUSE FIXATION WAS NOT ACHIEVED. THE LEAD WAS REMOVED. A FUNCTION TEST REVEALED THAT THE SCREW DID NOT SLOWLY UNSCREW BUT "SPRUNG OUT" AT ONE POINT. LEAD WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization