BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 340 DR-T

    MDR report key: 3010744 · Received March 19, 2013

    Report

    Report Number
    1028232-2013-00737
    Event Type
    Death
    Date Received
    March 19, 2013
    Date of Event
    September 19, 2012
    Report Date
    March 7, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE CARRIED OUT CORRECTLY. IN SUMMARY, THERE IS NO INDICATION OF A MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN UNKNOWN IMPLANTATION TIME, IT WAS REPORTED THAT THE PATIENT HAD DIED. THE PATIENT WAS SENT BY AMBULANCE TO THE HOSPITAL WHERE THE PATIENT EXPIRED ON THE SAME DAY. EVEN AFTER INQUIRIES, NO FURTHER INFORMATION REGARDING THE CAUSE OF DEATH WAS PROVIDED TO BIOTRONIK. (B)(6) 2013 - ON (B)(6) 2013 BIOTRONIK (B)(4) WAS NOTIFIED BY THE PROSECUTOR THAT NO AUTOPSY WOULD BE PERFORMED BECAUSE THERE WERE NO ISSUES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113717 LUMAX 340 DR-T ICD MRM BIOTRONIK SE & CO. KG 355267

    Patients

    Seq Age Sex Outcome Treatment
    1 Death