BEUDAMED
    FDA Adverse Event Other Summary report: N

    BEDSIDE

    MDR report key: 2699075 · Received August 13, 2012

    Report

    Report Number
    1218087-2012-00017
    Event Type
    Other
    Date Received
    August 13, 2012
    Manufacturer
    PACE MEDICAL, INC.
    Product Code
    DTE
    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 WITH NO PAPER WORK. UPON INSPECTION DEVICE WAS FOUND TO INDICATE, IT WAS PACING BUT NO OUTPUT PULSE WAS BEING DELIVERED. EXAMINATION SHOWED THAT THE OUTPUT SOCKET NEEDED TO BE RECONNECTED. DEVICE WAS RE-CALIBRATED AND FINAL TESTED. ALL TEST WERE PASSED. PACEMAKER WAS RETURNED TO CUSTOMER. REASON FOR FAULT: UNKNOWN. POSSIBLE ROUGH HANDLING OR OPENED BY EBME DEPARTMENT.

    Description of Event or Problem · 1

    PACE MEDICAL WAS NOTIFIED ON MARCH 15, 2011 BY (B)(6) VIA LETTER THAT UNIT HAD A FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEDSIDE TEMPORARY CARDIAC PACEMAKER DTE PACE MEDICAL, INC. 4170 NA

    Patients

    Seq Age Sex Outcome Treatment
    1