BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S 65

    MDR report key: 3002685 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00260
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS FOUND DISSECTED. ONLY THE IS-1 CONNECTOR WAS RECEIVED. THE MORPHOLOGY OF THE CUTTINGS INDICATES THAT THE FRAGMENTATION OF THE LEAD MOST LIKELY ORIGINATED FROM THE EXPLANT PROCEDURE. THE RETURNED DEVICE WAS VISUALLY AND ELECTRICALLY ANALYSED. THE INSPECTION OF THE INSULATION CONFIRMED THAT THE LEAD WAS, APART FROM THE PRESENT CUTTINGS, FREE OF INSULATION BREACHES. THE INSPECTION DEMONSTRATED DEFORMATIONS OF THE INNER COIL CLOSE TO THE IS-1 CONNECTOR PIN. THE SUBSEQUENT ANALYSIS INDICATED THAT THESE DAMAGES WERE CAUSED BY OVER ROTATION. THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. IN SUMMARY, NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM WAS NOTED DURING ANALYSIS.

    Description of Event or Problem · 1

    DURING AN IMPLANT, INITIAL HELIX EXTENSION WAS SUCCESSFUL. ATTEMPTING TO RETRACT THE HELIX TO REPOSITION WAS NOT SUCCESSFUL ALONG WITH ATTEMPTING TO RE-EXTEND THE HELIX AGAIN. TRIED TO ROTATE THE LEAD COUNTER-CLOCKWISE WITH A HEMOSTAT VALVE TO REMOVE TORQUE IN THE LEAD WAS UNSUCCESSFUL. FLUORO SHOWED LEAD STILL ATTACHED TO MYOCARDIUM. STYLET WAS UNABLE TO BE ADVANCED FURTHER THAN ABOUT 3 INCHES INTO THE LEAD WHEN NO INTRODUCER WAS BEING USED. PHYSICIAN DECIDED TO CUT AND CAP THE LEAD. REP IS SENDING BACK THE CUT PORTION. ON (B)(6) 2013 A PORTION OF THIS LEAD WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64204 LINOX SMART S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 369818

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization