BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151954 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01206
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC, INC.
    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 FOUND THAT THE LABEL WAS MISSING ITS COATING AND THAT THERE WAS A BROKEN LENS ON THE UPPER CASE. THE CABLE AND THE UPPER CASE WERE REPLACED AND THE PROGRAMMER HEAD PASSED ALL FUNCTIONAL AND SYSTEMS TESTS. NO OTHER ANOMALIES WERE FOUND. (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. (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 THAT THE RADIO FREQUENCY PROGRAMMER HEAD WAS EITHER MISSING ITS LABEL BACKING OR WAS HAVING TELEMETRY DIFFICULTY. FOLLOW-UP WITH THE SALES REPRESENTATIVE INDICATED THAT HE BELIEVED PAPERWORK HAD BEEN INCLUDED INDICATING WHICH HEADS HAD WHICH DIFFICULTY. THAT PAPERWORK IS NOT PRESENT IN THE EVENT FILE SO HE HAS NO WAY TO TELL US WHICH WAS WHICH. THE PROGRAMMER HEAD WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIO FREQUENCY PROGRAMMER HEAD WAS EITHER MISSING ITS LABEL BACKING OR WAS HAVING TELEMETRY DIFFICULTY. FOLLOW-UP WITH THE SALES REPRESENTATIVE INDICATED THAT HE BELIEVED PAPERWORK HAD BEEN INCLUDED INDICATING WHICH HEADS HAD WHICH DIFFICULTY. THAT PAPERWORK IS NOT PRESENT IN THE EVENT FILE SO HE HAS NO WAY TO TELL US WHICH WAS WHICH. THE PROGRAMMER HEAD WAS 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
    253301 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1