BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203482 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04810
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    July 6, 2012
    Report Date
    July 6, 2012
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# L67850, IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HEARD A SINGLE TONE ALARM ABOUT 1.5 HOURS BEFORE THE REPORT, AND THEN AGAIN JUST ABOUT THE TIME OF THE REPORT. IT WAS NOTED THAT THE PATIENT¿S PUMP HAD BEEN REFILLED THE PREVIOUS WEEK. THE PATIENT WAS HAD NOT EXPERIENCED ANY CHANGE IN THERAPEUTIC EFFECT OR NEGATIVE SYMPTOMS. THE PATIENT DID REPORT OTHER SYMPTOMS AND MEDICAL PROBLEMS. THE PATIENT REPORTED SYMPTOMS A PREVIOUS NIGHT FEELING LIKE SHE WAS PASSING OUT. IT WAS NOTED THAT SYMPTOM HAPPENED BEFORE THE PATIENT GOT THE PUMP. THE PATIENT ALSO REPORTED FEELING ¿RACY AND NERVOUS¿, BUT ATTRIBUTED THAT TO BEING NERVOUS/ANXIOUS ABOUT HEARING THE ALARM. THE PATIENT HAD ALSO HAD INJECTIONS FOR HEADACHES RECENTLY. THE PATIENT WAS REDIRECTED TO SEEK MEDICAL ATTENTION IF NEEDED, AND TO CONTACT THE PHYSICIAN TO INVESTIGATE THE REASON FOR THE ALARM. THE PUMP CONTAINED A MIXTURE OF CLONIDINE, BACLOFEN, AND MORPHINE AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS SEEN ON (B)(6) 2012. IT WAS DETERMINED THAT HE RESERVOIR VOLUME HAD NOT BEEN CHANGED/UPDATED AT THE PATIENT¿S REFILL. THE PATIENT HAD NO CHANGE IN THERAPY EXCEPT FOR THE INCONVENIENCE OF THE PUMP ALARMING. IT WAS NOTED THAT KETAMINE WAS ALSO IN THE PUMP. THE DEVICE WAS UPDATED THAT THE PATIENT¿S CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302297 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR