BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIA DR

    MDR report key: 3053741 · Received April 11, 2013

    Report

    Report Number
    1028232-2013-00951
    Event Type
    Death
    Date Received
    April 11, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    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. A MORE DETAILED ANALYSIS WILL BE PROVIDED IF THE DEVICE IS RETURNED TO BIOTRONIK. 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

    PATIENT DECEASED, UPON INTERROGATION, DEVICE DISPLAYED AN ERROR MESSAGE. CAUSE AND DATE OF DEATH ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155220 EVIA DR PACEMAKER DXY BIOTRONIK SE & CO. KG 359524

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death