BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3160308 · Received June 10, 2013

    Report

    Report Number
    2182208-2013-01821
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE ON THE ANALYZER WHILE PLACING A TEMPORARY PACING LEAD, SO THEY COULD PACE EXTERNALLY WITH THE INTERNAL PACEMAKER. NO OTHER PROGRAMMER/ANALYZER WAS AVAILABLE TO TROUBLESHOOT WITH. THE ANALYZER REMAINED IN USE FOR THE CASE AND WAS SUBSEQUENTLY REPLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259412 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2290

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER