BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/16

    MDR report key: 1033770 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00385
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 21, 2008
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MECHANICAL PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE FIXATION HELIX COULD BE PROPERLY EXTENDED AND RETRACTED. FURTHERMORE, THE MEASUREMENT RESULTS PROVED TO BE WITHIN THE VALUE RANGE DEFINED BY THE DESIGN SPECIFICATIONS, EVEN THOUGH COAGULATED BLOOD AND TISSUE RESIDUALS WERE FOUND WITHIN THE LEAD TIP THAT MAY COMPROMIZE THE EFFECTIVENESS OF THE FIXATION SCREW MECHANISM. THE CUTTINGS IN THE OUTER INSULATION ARE MOST LIKELY DUE TO THE EXPLANTATION PROCEDURE. THE DEFORMATION OF THE SHOCK COILS WAS DUE TO MECHANICAL FORCES. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. TRACTION FORCES DURING THE EXPLANTATION PROCEDURE SHOULD BE TAKEN INTO CONSIDERATION.

    Description of Event or Problem · 1

    THIS LEAD WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REP. PER THE OOS, THIS LEAD WAS BECAME DISLODGED AFTER ONE REPOSITIONING. THE PHYSICIAN REPLACED THE LEAD WITH A LINOX SD 65/18, DUE TO ITS WIDER SPACE BETWEEN SHOCKING COILS. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PT. PT RECORDS WAS UNABLE TO PROVIDE THE SEX OF THIS PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization