BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2951440 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00024
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROGRAMMER WAS NOT RECEIVED BY THE MANUFACTURER FOR ANALYSIS. HOWEVER, THE STYLUS WAS RECEIVED, AND THIS PART WAS ANALYZED. ANALYSIS REVEALED THAT AN INTERMITTENT OPEN CIRCUIT LOCATED AT THE CONNECTOR END PREVENTED PROPER OPERATION OF THE STYLUS. THE DEFECTIVE AREA WAS ISOLATED BY FLEXING THE CABLE AT THE STRAIN-RELIEF CONNECTOR END.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. NO PRODUCT WAS RETURNED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT THE PROGRAMMER'S TOUCH PEN (STYLUS) WAS NOT WORKING. THE DOCTOR STATED THAT SOMETIMES THERE WAS NO POSSIBILITY OF CHANGING THE SCREEN OR PROGRAMMING A NEW PARAMETER. THE TOUCH PEN WAS REPLACED AND EVERYTHING WORKED FINE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57775 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR