BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3160324 · Received June 10, 2013

    Report

    Report Number
    2182208-2013-01812
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT INTERROGATE A DEVICE WIRELESSLY OR WITH THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD. THE RF HEAD WAS SWAPPED OUT, BUT THE ISSUE REMAINED. THE SALES REP (SR) STATED THEY WOULD DOUBLE CHECK THE RF HEAD AGAIN AND SEND IT IN FOR REPAIR IF NEEDED. IT WAS LATER REPORTED BY THE SR THAT THE ISSUE WAS FOUND TO BE A BAD RF HEAD. THE RF HEAD WILL BE RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259699 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER