BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2812326 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03713
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 19, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 CONFIRMED THE REPORTED EVENT, THE PROGRAMMER ONLY HAD TELEMETRY WHEN THE RF HEAD CONNECTOR WAS PUSHED. THE PROGRAMMER ALSO FAILED FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PROGRAMMER WAS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER WAS UNABLE TO AUTO-IDENTIFY AND INTERROGATE BRADY DEVICES. THE RF (RADIO FREQUENCY) HEAD WAS CHANGED OUT AND FOUND THAT A DIFFERENT HEAD ALSO HAD THE SAME PROBLEM, YET BOTH HEADS WORKED FINE ON ANOTHER PROGRAMMER. THE PROGRAMMER IS BEING RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER WAS UNABLE TO AUTO-IDENTIFY AND INTERROGATE BRADY DEVICES. THE RF (RADIO FREQUENCY) HEAD WAS CHANGED OUT AND FOUND THAT A DIFFERENT HEAD ALSO HAD THE SAME PROBLEM, YET BOTH HEADS WORKED FINE ON ANOTHER PROGRAMMER. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR REPAIR. BOTH PRODUCTS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROGRAMMER WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2067 RF HEAD