BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3037053 · Received April 5, 2013

    Report

    Report Number
    3004209178-2013-04681
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, LOT# N179828001, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER: PRODUCT ID 8590-1, LOT# N165787, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S INFUSION SERVICE HAD "GOTTEN EXTRA" OUT OF THE PATIENT'S PUMP AT DIFFERENT TIMES AND THAT THEY HAD TO "WASTE A LITTLE BIT OF MEDICINE." ADDITIONAL INFORMATION WAS REQUESTED AND THE HEALTH CARE PROVIDER LATER REPORTED THAT SINCE 2004 THERE WAS NEVER A DISCREPANCY THAT WAS OUT OF THE LIMITS FOR WHAT WAS ACCEPTABLE. THERE WERE TIMES WHEN IT WAS NOT "SPOT ON" BUT ALWAYS WITHIN THE ACCEPTABLE LIMITS. THIS DEVICE SYSTEM DELIVERED MORPHINE. THE PATIENT ALSO REPORTED TAKING OXYCODONE AND ULTRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140398 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1