BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2864849 · Received December 10, 2012

    Report

    Report Number
    2182208-2012-04073
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    October 5, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    DXY
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THAT THE CABLE WAS DAMAGED, AS A RESULT THE CABLE WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIO FREQUENCY (RF) PROGRAMMER HEAD HAD A DAMAGED CORD. THE HEAD WAS RETURNED FOR SERVICE. THERE WAS NO INDICATION GIVEN AS TO ANY PATIENT IMPACT AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIO FREQUENCY (RF) PROGRAMMER HEAD HAD A DAMAGED CORD. THE HEAD WAS RETURNED FOR SERVICE. THERE WAS NO INDICATION GIVEN AS TO ANY PATIENT IMPACT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1