BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAMMER 2090X

    MDR report key: 2952200 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00143
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S065
    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE STYLUS/TOUCH SCREEN OUT OF CALIBRATION. AS A RESULT THE OVERLAY/BEZEL ASSEMBLY WAS REPLACED AND THE STYLUS WAS CALIBRATED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH PEN FOR THE PROGRAMMER IS OUT OF CALIBRATION, DESPITE HAVING BEEN UPDATED. IT WAS ALSO REPORTED THE X,Y COORDINATES ARE OFF ON THE TOUCH SCREEN. THE STYLUS CALIBRATION WAS RAN AND IT DID NOT HELP. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH PEN FOR THE PROGRAMMER IS OUT OF CALIBRATION, DESPITE HAVING BEEN UPDATED. IT WAS ALSO REPORTED THE X,Y COORDINATES ARE OFF ON THE TOUCH SCREEN. THE STYLUS CALIBRATION WAS RAN AND IT DID NOT HELP. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR REPAIR. BOTH PRODUCTS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57566 CARELINK PROGRAMMER 2090X PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ RICE CREEK MFG 2090X

    Patients

    Seq Age Sex Outcome Treatment
    1