BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINIATURE

    MDR report key: 2699055 · Received August 13, 2012

    Report

    Report Number
    1218087-2012-00021
    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 THAT THE RATE WAS UNSTABLE. UPON EXAMINATION, THE TECHNICIAN AT OUR FACILITY MADE A SOLDER REPAIR. AFTER THE SOLDER REPAIR, THE FAULT COULD NOT BE DUPLICATED. THE DEVICE WAS RE-CALIBRATED AND FINAL TESTED. ALL TESTS WERE NORMAL AND THE DEVICE WAS RETURNED TO THE CUSTOMER. CAUSE OF RATE INCREASE MAY HAVE BEEN DUE TO A POOR SOLDER CONNECTION EITHER CAUSED AT TIME OF MANUFACTURE OR FROM ROUGH HANDLING. CAUSE: UNKNOWN.

    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