BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/18

    MDR report key: 1073655 · Received July 8, 2008

    Report

    Report Number
    1028232-2008-00720
    Event Type
    Injury
    Date Received
    July 8, 2008
    Report Date
    June 10, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE ICD AND THE LEAD WERE NOT RETURNED FOR AN ANALYSIS. THUS, THE ANALYSIS IS BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE STERILIZATION OF THESE PRODUCTS WAS CHECKED. THE BIOTRONIK STERILIZATION PROTOCOLS CONFIRMED PROPER STERILIZATION. THE STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, AMONG OTHERS, WERE WITHIN THE SPECIFIED VALUES. THIS WAS ALSO CONFIRMED BY MICROBIOLOGICAL INDICATORS, WHICH PROVED A SUCCESSFUL STERILIZATION. IN SUMMARY, THE MFG DOCUMENTS PROOF A STERILIZATION CONFORMING TO THE SPECS. THE INFECTION WAS NOT CAUSED BY THE MEDICAL PRODUCTS.

    Description of Event or Problem · 1

    OUS MDR. IT WAS REPORTED TO US THAT THE ICD HAD BEEN IMPLANTED IN ANOTHER COUNTRY IN 2008. IN EARLY 2008, THE PT PRESENTED WITH SEPSIS. AFTER THE PT HAD BEEN STABILIZED ON THE INTENSIVE-CARE WARD, HE WAS MOVED TO ANOTHER FACILITY. THERE, THE ICD AND THE LEAD WERE REMOVED. THE PT WAS THEN TRANSFERRED TO THE CARDIOLOGY DEPT OF THE UNIV CLINIC GIEBEN. THE PT DIED THERE. THE ICD AND THE LEAD ARE NOT AVAILABLE FOR ANALYSIS. ADDITIONAL SYSTEM INFO: LUMAX 300 VR-T, MDR 1028232-2008-0719

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK GMBH AND CO. 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization