BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 3203505 · Received July 2, 2013

    Report

    Report Number
    6000030-2013-00066
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    July 11, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8709, LOT# J0058117R, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. PATIENT REPORTED PUMP DEPLETED MUCH QUICKER THAN SHE EXPECTED. REPORTED PUMP DIED IN NOT EVEN 5 YEARS DUE TO BATTERY DEPLETION. PATIENT FELT SHE WAS GOING TO DIE DUE TO WITHDRAWAL. PATIENT REPORTED SHE WENT TO HCP OFFICE IN MAY AS SHE WASN¿T FEELING WELL (BEFORE REFILL SCHEDULE), ACHED REALLY BAD AND EXPERIENCE FLU-LIKE SYMPTOMS (NAUSEA) AND NEXT MORNING SHE WAS SHIVERING AND COULDN'T MOVE AND REALIZED THAT SHE WAS EXPERIENCING WITHDRAWAL SYMPTOMS. PATIENT STATED THAT DURING THIS TIME SHE INITIALLY HEARD ONE LOUD BEEP BUT COULDN'T FIGURE OUT WHAT IT WAS AND 4 DAYS LATER HEARD ANOTHER BEEP. AND NEXT DAY WAS WHEN SHE STARTED TO NOTICE NOT FEELING WELL, NEXT DAY WENT TO HCP (5 DAYS BEFORE REFILL) AND WAS TOLD HCP DIDN'T FIND ANYTHING WRONG. SYSTEM USED TO DELIVER CLONIDINE, PRIALT, AND DILAUDID IF ADDITIONAL INFORMATION IS RECEIVED A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301442 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1