BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3143023 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01839
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP DEVICE WAS AT END OF LIFE/END OF SERVICE (EOL/EOS). THE REPORTER INDICATED THAT THE PUMP LOGS READ ON (B)(6) 2013 INDICATED EOS OCCURRED WITH ANOTHER MESSAGE WHICH SAID TO REPLACE THE PUMP BY (B)(6) 2013. THE PUMP ALSO HAD A MESSAGE OF ¿STOP PUMP MAY HAVE EXCEEDED TUBE SET¿. THE PUMP HAD BEEN STOPPED SINCE (B)(6) 2013. THE REPORTER NOTED THE EOS WAS NORMAL AND THE PUMP WAS BEING REPLACED THE DAY OF REPORT AS WELL, BUT THE REPORTER WAS UNSURE IF THE ELECTIVE REPLACEMENT INDICATOR (ERI) DATE WAS MISSED ¿OR WHAT HAPPENED¿. THE PATIENT DID NOT HAVE ANY SYMPTOMS RELATED TO THE EVENT. THE PUMP WAS USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THAT THE PUMP WAS DISCARDED AT THE HOSPITAL, THUS IT WAS NOT TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244988 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1