BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2810416 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03677
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 5, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN AN ANALYZER SESSION, SENSING MARKERS WERE UNABLE TO BE OBTAINED. ANALYZER WAS CHANGED OUT AND ISSUE WAS THEN CORRECTED. THEREFORE CONCLUSION WAS THERE IS AN ISSUE WITH THE ANALYZER AND NOT THE PROGRAMMER. THE ANALYZER IS BEING RETURNED FOR CHECKOUT/REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN AN ANALYZER SESSION, SENSING MARKERS WERE UNABLE TO BE OBTAINED. ANALYZER WAS CHANGED OUT AND ISSUE WAS THEN CORRECTED. THEREFORE CONCLUSION WAS THERE IS AN ISSUE WITH THE ANALYZER AND NOT THE PROGRAMMER. THE ANALYZER IS BEING RETURNED FOR CHECKOUT/REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN AN ANALYZER SESSION, SENSING MARKERS WERE UNABLE TO BE OBTAINED. ANALYZER WAS CHANGED OUT AND ISSUE WAS THEN CORRECTED. THEREFORE CONCLUSION WAS THERE IS AN ISSUE WITH THE ANALYZER AND NOT THE PROGRAMMER. THE ANALYZER IS BEING RETURNED FOR CHECKOUT/REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other