BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3102740 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01567
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J0056602R, IMPLANTED: (B)(6) 2000. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO SIGNIFICANT ANOMALY; END OF SERVICE DUE TO TIME PROGRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTHCARE PROVIDER (HCP) MISSED THE UPCOMING ELECTIVE REPLACEMENT INDICATOR (ERI) / END OF SERVICE (EOS) EVENT. THE PUMP LOG INDICATED EOS OCCURRED (B)(6) 2013. THE PUMP WAS "WORKING FINE" THE LAST SUMMER, WHICH WAS THE LAST TIME THE PATIENT WAS SEEN BY THE PROVIDER. THE PUMP WAS REPLACED WITHOUT COMPLICATION, AND FILLED WITH THE SAME MEDICATION AND CONCENTRATION. THE PUMP WAS DELIVERING SUFENTANYL 300 MCG/ML AT 85 MCG/DAY AND BACLOFEN WAS ALSO IN THE SYRINGE OF MEDS WITH A CONCENTRATION OF 30 MCG/ML AT 15 MCG/DAY. THE PATIENT DID NOT HAVE WITHDRAWAL AND WAS MANAGED WITH ORAL MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203684 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR