BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2864822 · Received December 10, 2012

    Report

    Report Number
    2182208-2012-04060
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC, INC., RICE CREEK MFG
    Product Code
    KRG
    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 FOUND THAT THE CABLE WAS DAMAGED, HOWEVER THE DEVICE WAS ABLE TO INTERROGATE AN IMPLANTED DEVICE WITH NO FAULT FOUND. (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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STYLUS CONNECTOR WAS NOT WORKING PROPERLY. THE STYLUS WORKED INTERMITTENTLY, EVEN AFTER REPLACING IT WITH A NEW ONE. ALSO, THE SCREEN WAS MISSING SCREWS. THE PROGRAMMER WAS RETURNED FOR REPAIR. THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD WAS RETURNED WITH THE PROGRAMMER BECAUSE IT HAD A BREAK IN THE INSULATION ON THE CORD. THERE WERE NO PERFORMANCE ISSUES EXPERIENCED. RF HEAD REPLACEMENT WAS REQUESTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE STYLUS CONNECTOR WAS NOT WORKING PROPERLY. THE STYLUS WORKED INTERMITTENTLY, EVEN AFTER REPLACING IT WITH A NEW ONE. ALSO, THE SCREEN WAS MISSING SCREWS. THE PROGRAMMER WAS RETURNED FOR REPAIR. THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD WAS RETURNED WITH THE PROGRAMMER BECAUSE IT HAD A BREAK IN THE INSULATION ON THE CORD. THERE WERE NO PERFORMANCE ISSUES EXPERIENCED. RF HEAD REPLACEMENT WAS REQUESTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC., RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER