BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRO-PACE

    MDR report key: 2521024 · Received March 28, 2012

    Report

    Report Number
    1218087-2012-00002
    Event Type
    Death
    Date Received
    March 28, 2012
    Date of Event
    March 26, 2012
    Manufacturer
    PACE MEDICAL, INC.
    Product Code
    JOQ
    PMA / PMN Number
    P920032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PACE MEDICAL WAS NOTIFIED (B)(6) 2012 BY MR (B)(6) VIA EMAIL, A FOLLOW UP TELEPHONE CONVERSATION THAT A REF 4580 MICRO-PACE TEMPORARY CARDIAC PACEMAKER WAS IN USE AT THE TIME OF THE PT'S DEATH. AT THIS TIME, THERE IS NO INDICATIONS THAT THE DEVICE WAS INVOLVED WITH THE PT'S DEATH. NO REPORT HAS BEEN FILED BY THE HOSPITAL OR MEDICAL PROFESSIONAL. PACE MEDICAL, THROUGH ITS EUROPEAN REP, (B)(4), IS FOLLOWING UP ON THIS INCIDENT AND HAS REQUESTED THAT THE DEVICE AND ANY INFO SUCH AS AN ECK RECORDING BE SENT TO THE COMPANY FOR ANALYSIS. THE SERIAL NUMBER (B)(4), HAS NOT BEEN CONFIRMED BY THE USER AS THE DEVICE IN OPERATION BUT IS "THOUGHT" TO BE THE DEVICE. FURTHER INVESTIGATION HAS BEEN REQUESTED THROUGH THE DISTRIBUTOR BY PACE MEDICAL TO IDENTIFY THE EXACT SERIAL NUMBER IF POSSIBLE. THIS IS AN INITIAL REPORT AND CONTAINS ALL KNOWN INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-PACE TEMPORARY CARDICAC PACEMAKER JOQ PACE MEDICAL, INC. 4580 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death