BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 3405027 · Received October 10, 2013

    Report

    Report Number
    2182208-2013-03096
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    July 24, 2013
    Report Date
    July 24, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIOMEDICAL ENGINEER WAS USING A SIGMA PACE 1000 AND THE SWITCHED TEST LEADS ON THE EXTERNAL PULSE GENERATOR (EPG) AND THE ATRIAL CHANNEL WAS MEASURING OUT OF SPECIFICATION FOR THE VENTRICULAR CHANNEL. THE BIOMEDICAL ENGINEER USED AN OSCILLOSCOPE AND DETERMINED THAT THE ISSUE WAS WITH THE PATIENT CABLE AND NOT THE EPG. ALSO, THE BATTERY DRAWER ON THE EPG WAS SOMEWHAT DIFFICULT TO OPEN, WHICH CAUSED THE PLASTIC END OF THE CAP TO BE PULLED OFF. THE THREE BOTTOM SCREWS WERE LOOSENED A QUARTER TURN AND THE ISSUE WAS RESOLVED. THE EPG REMAINS IN USE, HOWEVER THE PATIENT CABLE WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520641 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE RICE CREEK MFG MDT-CABLE

    Patients

    Seq Age Sex Outcome Treatment
    1