BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIATURE

    MDR report key: 2596203 · Received May 29, 2012

    Report

    Report Number
    1218087-2012-00001
    Event Type
    Injury
    Date Received
    May 29, 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'S COMPLAINT OF DEVICE'S ALLEGED FAULT COULD NOT BE DUPLICATED. GENERAL REVIEW AND PROPHYLACTIC MAINTENANCE PERFORMED ON THE DEVICE. RETURNED TO CUSTOMER. INFO FILED UNDER (B)(4).

    Description of Event or Problem · 1

    DEVICES RETURNED TO (B)(4), PACE MEDICAL'S (B)(4) REP AND WHOLLY OWNED SUBSIDIARY ON (B)(4) 2011. NO HOSP REPORT SENT HOWEVER IT WAS IDENTIFIED BY THE USER AS HAVING BEEN INVOLVED IN A PT CARDIAC ARREST. DEVICE WAS BENCH TESTED AND THE FOLLOWING REPAIRS PERFORMED. RE-FLOWED SOLDER ON RATE ADJUSTMENT POTENTIOMETER. REPLACED A DIODE. DEVICE THEN RE-CALIBRATED AND FINAL TEST PERFORMED. DEVICE PASSED ALL TESTS AND RETURNED TO CUSTOMER. ALL TESTS COMPLETED BY (B)(4) 2011. NO ISSUES SINCE THE DEVICE WAS RETURNED TO USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other