BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINIATURE

    MDR report key: 2699154 · Received August 13, 2012

    Report

    Report Number
    1218087-2012-00026
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED DEVICE WITH THE COMPLAINT THAT THERE WAS NO RAPID PACING AND RATE VALUES OUT OF RANGE. TECHNICIAN ANALYZED THE DEVICE AND PERFORMED A SOLDER REPAIR TO A COMPONENT. DEVICE PERFORMED AS INTENDED. DEVICE WAS RE-CALIBRATED AND FINAL TESTED. ALL TESTS PASSED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. REASON FOR FAULT: UNKNOWN. MAY HAVE BEEN CAUSED BY A MFG DEFECT OR ROUGH HANDLING / SUDDEN IMPACT.

    Description of Event or Problem · 1

    PACE MEDICAL WAS NOTIFIED ON MAY 16, 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