BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2951473 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00040
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    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

    EVALUATION SUMMARY: THE PROGRAMMER WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT IT WOULD NOT BOOT COMPLETELY, THERE WAS DEVICE LOCK-UP AND THE PRINTED CIRCUIT BOARD WAS OUT OF SPECIFICATION. (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 THAT THE PROGRAMMER FAILED TO BOOT UP. THE LOGO WAS DISPLAYED, BUT DID NOT CONTINUE WITH THE START-UP. TECHNICAL SERVICES (TS) RECOMMENDED THAT THE SERVICE DISK BE TRIED. THIS CLIENT TRIED THE DISK AND THE PROGRAMMER STILL "HANGS" AND THE SERVICE DISK DID NOT RUN. THE PROGRAMMER WILL BE RETURNED FOR SERVICE. ANOTHER PROGRAMMER WAS USED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PROGRAMMER WAS RETURNED FOR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER FAILED TO BOOT UP. THE LOGO WAS DISPLAYED, BUT DID NOT CONTINUE WITH THE START-UP. TECHNICAL SERVICES (TS) RECOMMENDED THAT THE SERVICE DISK BE TRIED. THIS CLIENT TRIED THE DISK AND THE PROGRAMMER STILL "HANGS" AND THE SERVICE DISK DID NOT RUN. THE PROGRAMMER WILL BE RETURNED FOR SERVICE. ANOTHER PROGRAMMER WAS USED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57051 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1