BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIATURE

    MDR report key: 2701438 · Received August 13, 2012

    Report

    Report Number
    1218087-2012-00049
    Event Type
    Malfunction
    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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED THE DEVICE STATING THAT THE OUTPUT CONTROL WAS INTERMITTENT. THE DEVICE WAS ANALYZED AND TESTED FOR 2 DAYS AND 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 COMPLAINT: USER ERROR.

    Description of Event or Problem · 1

    PACE MEDICAL WAS NOTIFIED ON (B)(6) 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