BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2811224 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01852
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 24, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD NO ATRIAL OUTPUT WHEN TRYING TO MEASURE WITH A DEFIBRILLATOR TRANSCUTANEOUS PACING TESTER; NO OTHER TESTER AVAILABLE. TECHNICAL SUPPORT (TS) HAD THE CLINICIAN CONNECT VENTRICULAR LEADS TO ATRIAL CHANNEL AND INCREASE RATE TO 180 AND OUTPUT TO 20 MA; NO MEASUREMENT. TS RECOMMENDED THE EPG BE RETURNED TO SERVICE FOR TESTING AND CALIBRATION; EMAILED RETURN FORM. THE EPG WAS RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other