BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151962 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01198
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 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

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT. THE RF (RADIO FREQUENCY) HEAD HAD NO TELEMETRY AND FAILED ALL UPLINK AMPLITUDE TESTS. RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. IT IS NOTED THE RUBBER PORTION OF THE RF HEAD LABEL WAS MISSING.

    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 THERE WAS DIFFICULTY IN INTERROGATING DEVICES. THE PROGRAMMER HEAD HAD TO BE HELD A CERTAIN WAY IN ORDER TO DO PATIENT CHECKS. THE PROGRAMMER HEAD WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252422 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1