BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPUS RM

    MDR report key: 250994 · Received November 24, 1999

    Report

    Report Number
    2182863-1999-00038
    Event Type
    Injury
    Date Received
    November 24, 1999
    Date of Event
    June 30, 1997
    Report Date
    November 24, 1999
    Manufacturer
    ELA MEDICAL, S.A.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED AFTER 10 DAYS OF IMPLANTATION, BECAUSE OF POCKET INFECTION. THE DEVICE WAS NOT RETURNED TO THE CO FOR APPROX 2 YRS AFTER THE EXPLANT. ELA MED, LLC WAS NOT NOTIFIED OF THIS EXPLANT UNTIL FEBRUARY 23, 1999, BY THE PHYSICIANS NURSE. PROCEDURE INDICATES THAT THE MEDICAL DEVICE TRACKING PERSONNEL NOTIFY THE Q.A. DEPT OF ALL EXPLANTS, OTHER THAN EOL OR ERI. THIS WAS NOT DONE. THE EMPLOYEE IS NO LONGER WITH THE CO. THE CURRENT DEVICE TRACKING PERSONNEL HAS BEEN TRAINED TO REPORT ALL SUCH EVENTS AND WAS INFORMED OF THIS OCCURRANCE AS A REMINDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUS RM Implant CARDIAC PACEMAKER DXY ELA MEDICAL, S.A. 4534 S970313

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R