BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4232994 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21100
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. THE PATIENT WAS SEEN FOR A REFILL ON THE DAY OF THE REPORT AND THE EVENT LOGS SHOWED THAT A ¿PUMP RESET¿ AND ¿PUMP IS IN SAFE STATE¿ OCCURRED ON THE DAY PRIOR TO THE REPORT. THE PATIENT REPORTEDLY HEARD THE ALARM AROUND 12:45 HOURS. THE PATIENT EXPERIENCED INCREASED TONE, SPASTICITY, AND PAIN. BEFORE THE PUMP WAS REFILLED, THE PATIENT RECEIVED A 25MCG BOLUS AND REPORTED FEELING BETTER AFTER, BUT THE PATIENT STILL FELT SLEEPY. THE TIMING OF THE SYMPTOMS WAS REPORTEDLY CONSISTENT WHEN THE PUMP WENT INTO SAFE STATE. THE REPORTER WAS INSTRUCTED TO PROGRAM THE PUMP BACK TO THE DESIRED PRESCRIPTION AND TO MONITOR THE PUMP AND PATIENT GOING FORWARD. THE RESERVOIR VOLUME WAS STATED TO BE WITHIN THE EXPECTED RANGE. IT WAS ALSO STATED THAT THE PATIENT FELT BETTER AFTER THE REFILL. THE PATIENT WAS TO BE SUPPLEMENTED WITH ORAL MEDICATION (BACLOFEN AND OXYCODONE), SHOULD SHE EXPERIENCE WITHDRAWAL SYMPTOMS. IT WAS THOUGHT THAT THE PATIENT SHOULD NOT NEED ANY FURTHER ORAL BACLOFEN AT THIS POINT. THE SAFE STATE DID NOT OCCUR DURING A PUMP UPDATE, WHILE A FLEX BOLUS WAS IN USE, OR ASSOCIATE WITH ELECTROMAGNETIC INTERFERENCE (EMI) OR MRIS. THE PUMP WAS USED TO DELIVER MORPHINE, BUPIVACAINE, AND BACLOFEN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714734 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR