BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRO-PACE

    MDR report key: 2699063 · Received August 13, 2012

    Report

    Report Number
    1218087-2012-00031
    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
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED DEVICE STATING THE ON/OFF SWITCH WAS STUCK. THE DEVICE WAS ANALYZED AND IT WAS FOUND THAT THERE WAS EXCESSIVE GLUE AROUND THE SWITCH. THE SWITCH WAS CLEANED. THE DEVICE WAS RE-CALIBRATED AND FINAL TESTED. ALL TESTS PASSED. THE DEVICE WAS RETURNED TO THE CUSTOMER. REASON FOR COMPLAINT: UNKNOWN.

    Description of Event or Problem · 1

    PACE MEDICAL WAS NOTIFIED ON JUNE 1, 2011 BY (B)(6) VIA 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. 4570 NA

    Patients

    Seq Age Sex Outcome Treatment
    1