BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRO PACE

    MDR report key: 2699200 · Received August 13, 2012

    Report

    Report Number
    1218087-2012-00056
    Event Type
    Other
    Date Received
    August 13, 2012
    Manufacturer
    PACE MEDICAL, INC
    Product Code
    JOQ
    PMA / PMN Number
    P920032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED A DISPLAY ERROR MESSAGE. THE DEVICE WAS EXAMINED FOR THE DISPLAY ERROR MESSAGE MENTIONED "MALL" WHICH IS AN IMPOSSIBLE CODE FOR THE DISPLAY TO PRODUCE. AFTER MUCH DISCUSSION IT WAS DISCOVERED THIS WAS A TRANSLATION ISSUE FROM THE FRENCH LANGUAGE AND THE CUSTOMER MEANT TO SAY "POOR" SENSING. SENSING TESTS WERE PERFORMED AND THE DEVICE APPEARED TO FUNCTION NORMALLY. WORKING WITH THE EBME STAFF AT THE HOSP IT WAS UNCOVERED THAT HEART WIRES WITH VERY HIGH IMPEDANCES COULD CAUSE SENSING ISSUES. THE DEVICES WERE RECALLED AND WAIVERS WERE APPLIED TO THEM. ALL AFFECTED SERIAL NUMBERS WERE RECALLED TO BE MODIFIED. ALL DEVICES WERE OUTSIDE THE UNITED STATES. REASON FOR COMPLAINT: DEVICE SENSING CIRCUIT WAS MODIFIED TO WORK BETTER WITH HIGH IMPEDANCE HEART WIRES.

    Description of Event or Problem · 1

    PACE MEDICAL WAS NOTIFIED ON 09/30/2011 BY (B)(6) FROM APCC NETHERLANDS BY LETTER THAT UNIT HAD A FAULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1