BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5411336 · Received February 4, 2016

    Report

    Report Number
    3004209178-2016-01570
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    January 10, 2016
    Report Date
    January 11, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER AND MANUFACTURING REPRESENTATIVE REGARDING A PUMP SYSTEM BEING USED TO DELIVER MORPHINE. THE DIAGNOSIS FOR USE OF THE SYSTEM WAS CANCER. PRIOR TO IMPLANTATION OF THE PUMP ON (B)(6) 2016, THE CURRENT PUMP SETTINGS SHOWED THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS 81 MONTHS. AFTER SURGERY, THE SURGEON SET THE INFUSION DRUG CONCENTRATION AND NOTICED FROM THE PROGRAMMER THE PUMP STATUS AFTER UPDATE SHOWED ERI WAS 49 MONTHS. THE CHANGE OF ERI RAISED CONCERN OF THE SURGEON. WHEN THE PHYSICIAN DID THE PATIENT INPUT THE SECOND TIME TO ADJUST THE DRUG CONCENTRATION, THE ERI DATA WENT BACK TO NORMAL. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. OTHER MEDICATIONS TAKEN AT THE TIME OF THE EVENT AND PERTINENT PATIENT MEDICAL HISTORY WAS REQUESTED BUT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68882 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1