BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINOX SD 65/16

    MDR report key: 1661280 · Received April 12, 2010

    Report

    Report Number
    1028232-2010-00658
    Event Type
    Death
    Date Received
    April 12, 2010
    Date of Event
    February 4, 2010
    Report Date
    March 9, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS, THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT THE PATIENT DIED ABOUT 4 MONTHS AFTER IMPLANTATION. THE PATIENT WAS KNOWN TO HAVE CHF AT THE END STAGE, CHRONIC RENAL FAILURE AND ISCHEMIC HEART DISEASE. IT IS UNKNOWN IF THE LEAD WAS EXPLANTED OR BURIED WITH THE PATIENT. NO EXPLANT DATE WAS PROVIDED AND DEVICE WAS NOT RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death