BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 3053624 · Received April 11, 2013

    Report

    Report Number
    1028232-2013-00944
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 5, 2013
    Report Date
    March 29, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    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. THE RETURNED FRAGMENT HAS A LENGTH OF 6 CM. THE PROXIMAL PART AND THE DISTAL PART OF THE LEAD WERE NOT RETURNED FOR ANALYSIS. THE INSPECTION OF THE FRAGMENT REVEALED A FRACTURE OF THE CONDUCTOR CABLES TO RV SHOCK COIL AND TO THE RING ELECTRODE. BASED ON THE CHARACTERISTICS OF THE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL STRESS. TRACTION FORCES DURING THE EXPLANTATION SHOULD BE TAKEN INTO CONSIDERATION. THE BIOTRONIK STERILIZATION PROTOCOL CONFIRMED THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., WERE IN THEIR SPECIFIED RANGES. ALSO, THE INVESTIGATION OF THE MICROBIOLOGICAL INDICATORS SHOWED THE SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. IN SUMMARY, THE INFECTION WAS NOT DEVICE RELATED. NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM WAS NOTED DURING THE ANALYSIS OF THE AVAILABLE LEAD FRAGMENT.

    Description of Event or Problem · 1

    THIS DEVICE AND THE ASSOCIATED LEAD WERE EXPLANTED SOMETIME IN (B)(6) 2013. THE DEVICE WAS BEING REMOVED FOR AN UNKNOWN REASON WHEN IT WAS NOTED THE DAMAGE TO THE LEAD FOLLOWING THE EXTRACTION PROCEDURE BY HOSPITAL PERSONNEL. AT THIS TIME, NEITHER PART OF THIS SYSTEM HAS BEEN RETURNED FOR ANALYSIS AND NO INDICATION WAS GIVING THAT THE SYSTEM WAS REPLACED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. (B)(6) 2013 - THE REASON FOR INITIALLY GOING IN FOR A REVISION OF THE ICD WAS DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155876 LINOX SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization