BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2951806 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00102
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND, THE EVENT COULD NOT BE CONFIRMED. CONCOMITANT PRODUCT: PRODUCT ID 2090 PROGRAMMER.

    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 THE CONNECTION FROM THE PROGRAMMER WAND AND THE PROGRAMMER IS NOT TIGHT PHYSICALLY OR ELECTRICALLY. IT SEEMS TO BE L OOSE, AND GIVES TECHNICIANS THOUGHTS THAT THE PROGRAMMER WAND ITSELF IS BROKEN. THE PROGRAMMER AND PROGRAMMER WAND WERE RETURNED FOR REPAIR AND CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56488 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 2090W PROGRAMMER