BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153264 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01404
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS CONNECTED TO THE EXTERNAL PULSE GENERATOR (EPG) THE MONITOR DISPLAYED "ARTIFACTS." THIS WAS THE SECOND TIME THE CALLER HAD SEEN THIS HAPPEN. OF NOTE, THERE ARE ADDITIONAL PACING FLAGS IN THE MARKER CHANNEL AND THEY "ARE IN THE WRONG SPOT FOR THE QRS." THE EPG WAS SWAPPED OUT FOR ANOTHER AND THE ISSUE REMAINED. ONCE THE PACING WAS CHANGED TO SINGLE CHAMBER INSTEAD OF DOUBLE CHAMBER, THE ISSUE "WENT AWAY." ALSO, IF THE PACING MARKER CHANNEL IS REMOVED OR THE PUMP WAS UNPLUGGED, THE ISSUES "GOES AWAY." THE CALLER WILL PROVIDE ADDITIONAL INFORMATION, BUT HAS NOT OF YET. THE STATUS OF THE EPG IS UNKNOWN. THE PATIENT WAS FINE, "NO ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256082 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MFG 5388

    Patients

    Seq Age Sex Outcome Treatment
    1