BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3022856 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04280
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8832, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8703W, LOT# L50555, IMPLANTED: (B)(6) 1998. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED A REFILL APPOINTMENT ABOUT TWO WEEKS PRIOR TO REPORT, DUE TO CONCERNS WITH HIS PHYSICIAN. AS A RESULT, THE RESERVOIR WAS EMPTY AND THE PATIENT HAD HEARD TWO PUMP ALARMS. ADDITIONALLY, THE ERROR CODE FOR AN EMPTY RESERVOIR WAS SEEN ON THE PATIENT'S PERSONAL THERAPY MANAGER. IT WAS STATED THAT THERE HAD ALSO BEEN ANOTHER ERROR CODE SEEN, THOUGH THE SPECIFIC CODE WAS UNKNOWN. WHILE THE PATIENT HAD MEDICATION IN THE PUMP RESERVOIR, HE WOULD EXPERIENCE NUMBNESS IN HIS TOES, WHICH THE REPORTER THOUGHT WAS RELATED TO THE AMOUNT OF NUMBING AGENT IN THE PUMP. IT WAS ALSO REPORTED THAT THE PATIENT WAS UNABLE TO SLEEP DUE TO THE MEDICATION, PROVIGIL, BEING IN THE PUMP. WHEN ATTEMPTING TO SLEEP, HIS EYES WOULD "POP BACK OPEN" AND HE WOULD FEEL LIKE HE WAS "ON SPEED OR DRANK THIRTY CUPS OF COFFEE." IT WAS STATED THAT THE PATIENT HAD BEEN "UP FOR OVER TWO MONTHS." AT THE TIME OF REPORT, THE PATIENT WAS THOUGHT TO HAVE DILAUDID, FENTANYL, BACLOFEN, BUPIVACAINE, AND PROVIGIL IN HIS PUMP. HOWEVER, THE REPORTER WAS UNSURE OF THE DRUGS OUTSIDE OF THE DILAUDID, BACLOFEN, AND PROVIGIL. IT WAS ALSO NOTED THAT THERE HAD BEEN TIMES WHERE THE PATIENT HAD EITHER SOLELY FENTANYL OR PRESERVATIVE-FREE MORPHINE SULFATE IN HIS PUMP, THOUGH IT WAS UNKNOWN AT WHICH TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126314 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1