BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 540 DR-T

    MDR report key: 3246714 · Received July 25, 2013

    Report

    Report Number
    1028232-2013-02033
    Event Type
    Death
    Date Received
    July 25, 2013
    Date of Event
    November 13, 2012
    Report Date
    July 15, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF 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. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THIS PATIENT WAS FOUND PULSELESS AT HOME. THE RHYTHMS WERE PEA AND V-FIB PER EVAC. HE WAS DEFIBRILLATED 2 TIMES, ICD FIRED 15 TIMES. HE WAS GIVEN 2 ROUNDS OF EPI WITH NO RESPONSE. PUPILS FIXED AND DILATED UPON ARRIVAL TO ER WITH NO RESPIRATIONS. HE WAS INTUBATED. AT ED HE WAS GIVEN 1 ROUND OF EPINEPHRINE AND CPR WAS CONTINUED WITH NO RETURN OF SPONTANEOUS CIRCULATION. HE WAS PRONOUNCED DEAD AT 05:42 AM (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349198 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death