BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2812141 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03712
    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/S080
    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.

    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. PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED EVENT CONCERNING THE ERROR, THE DEVICE POWERED UP CORRECTLY. IT WAS NOTED THAT THERE WAS WATER DAMAGE TO THE DEVICE AND PARTICULARLY HEAVY DAMAGE IN THE DISPLAY AREA, ALSO THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE ON THE LINK ELECTRONIC MODULE (LEM) BOARD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PROGRAMMER WAS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PROGRAMMER WAS POWERED ON A SYSTEM ERROR WAS DISPLAYED. THERE IS A POSSIBILITY THAT THE PROGRAMMER GOT WET FROM A WATER MISHAP AT THE HOSPITAL. THE PROGRAMMER IS BEING RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PROGRAMMER WAS POWERED ON A SYSTEM ERROR WAS DISPLAYED. THERE IS A POSSIBILITY THAT THE PROGRAMMER GOT WET FROM A WATER MISHAP AT THE HOSPITAL. THE PROGRAMMER IS BEING RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4) ANALYZER