BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152603 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01538
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE SCREEN WAS "OFF" FROM WHERE THE STYLUS TOUCHED IT. THE OVERLAY/BEZEL ASSEMBLY WAS REPLACED AND THE STYLUS CALIBRATED. CONCOMITANT PRODUCTS: PRODUCT ID 2067L RADIO FREQUENCY PROGRAMMER HEAD; PRODUCT ID 229047 SOFTWARE ANALYZER. (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. (B)(4).

    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 BY A SALES REPRESENTATIVE (SR) THAT THE STYLUS PEN ON THE PROGRAMMER IS OFF FROM WHERE IT TOUCHES THE SCREEN. TECHNICAL SUPPORT (TS) RECOMMENDED THAT THE SR USE THE CALIBRATION FUNCTION ON THE PROGRAMMER. THIS WAS DONE AND THE TOUCH PEN WAS REPLACED; HOWEVER THAT DID NOT RESOLVE THE ISSUE. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SALES REPRESENTATIVE (SR) THAT THE STYLUS PEN ON THE PROGRAMMER IS OFF FROM WHERE IT TOUCHES THE SCREEN. TECHNICAL SUPPORT (TS) RECOMMENDED THAT THE SR USE THE CALIBRATION FUNCTION ON THE PROGRAMMER. THIS WAS DONE AND THE TOUCH PEN WAS REPLACED; HOWEVER THAT DID NOT RESOLVE THE ISSUE. TS STATED THAT IF CALIBRATION DOES NOT CORRECT THE ISSUE, THE PROGRAMMER SHOULD BE RETURNED FOR REPAIR. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252115 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1