BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2952545 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00185
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE REPORTED EVENT COULD NOT BE CONFIRMED; THE RF (RADIO FREQUENCY) HEAD PASSED FUNCTIONAL TESTING. ANALYSIS FOUND THE RUBBER PORTION OF THE RF HEAD LABEL IS MISSING (DAMAGED).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD WAS NOT FUNCTIONING. DETAILS OF THE SPECIFIC ISSUES WERE NOT AVAILABLE. THE RF HEAD WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57346 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1