BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINIATURE

    MDR report key: 2699054 · Received August 13, 2012

    Report

    Report Number
    1218087-2012-00020
    Event Type
    Other
    Date Received
    August 13, 2012
    Manufacturer
    PACE MEDICAL, INC.
    Product Code
    DTE
    PMA / PMN Number
    K870323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED DEVICE COMPLAINING OF UNSTABLE RATE. TECHNICIAN EXAMINED DEVICE AND REPAIRED A SOLDER JOINT. AFTER REPAIR, THE FAULT COULD NOT BE DUPLICATED. THE DEVICE WAS RE-CALIBRATED AND FINAL TESTED. ALL TESTS WERE PASSED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. REASON FOR FAULT IS UNKNOWN. POSSIBLE SOLDER JOINT FAILURE DUE TO MANUFACTURING OR ROUGH HANDLING.

    Description of Event or Problem · 1

    PACE MEDICAL WAS NOTIFIED ON APRIL 8, 2011 BY (B)(6) VIA LETTER THAT UNIT HAD A FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIATURE TEMPORARY CARDIAC PACEMAKER DTE PACE MEDICAL, INC. EV4543 NA

    Patients

    Seq Age Sex Outcome Treatment
    1