BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203554 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-03235
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    July 6, 2012
    Report Date
    July 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER; PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL WITH SYMPTOMS OF NAUSEA, SWEATING, AND PAIN. ALARM DATE FOR DRUG REFILL WAS (B)(6) 2012, BUT THE REFILL APPOINTMENT WAS NOT SCHEDULED. SEVEN DAYS LATER IT WAS REPORTED THE PATIENT EXPERIENCED THE WITHDRAWAL SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. THE DEVICE SYSTEM WAS USED TO DELIVER AN UNKNOWN DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304794 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR