BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152279 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01572
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 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 COULD NOT CONFIRM THE CUSTOMER COMMENTS THAT THERE WAS LATENCY WITH THE SENSING AND THRESHOLD TESTING, NOR THAT IT TOOK AWHILE FOR THE TEST TO END WHEN CAPTURE WAS LOST AND THAT THERE WAS NOISE ON THE ELECTROCARDIOGRAM (ECG). IT WAS NOTED THAT NO ECG CABLES WERE SENT IN WITH THE DEVICE, BUT REPAIR WAS CONTINUED AND THE HARD DISK DRIVE WAS REIMAGED AND THE CURRENT SOFTWARE RELOADED AS A PREVENTATIVE MEASURE. ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMER COMMENT THAT "THERE WERE BROKEN GREY PIECES FROM THE SIDE OF THE PRINTER AND THE PIECES ARE INSIDE WHERE THE WAND NORMALLY IS" AND THEREFORE THE PRINTER DRAWER WAS REPLACED. (B)(4).

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SHOWED NOISE ON THE ELECTROCARDIOGRAM (EKG) AND LATENCY WITH THE SENSING AND THRESHOLD TESTING. IT WAS NOTED IT TAKES A WHILE FOR TEST TO END WHEN CAPTURE IS LOST. THERE ARE BROKEN GRAY PIECES FROM SIDE OF PRINTER AND THE PIECES ARE INSIDE WHERE WAND NORMALLY IS. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SHOWED NOISE ON THE ELECTROCARDIOGRAM (EKG) AND LATENCY WITH THE SENSING AND THRESHOLD TESTING. IT WAS NOTED IT TAKES A WHILE FOR TEST TO END WHEN CAPTURE IS LOST. THERE ARE BROKEN GRAY PIECES FROM SIDE OF PRINTER AND THE PIECES ARE INSIDE WHERE WAND NORMALLY IS. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252931 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1