BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5405439 · Received February 2, 2016

    Report

    Report Number
    3004209178-2016-01394
    Event Type
    Malfunction
    Date Received
    February 2, 2016
    Report Date
    January 11, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FAMILY MEMBER REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND A HEAD/BRAIN INJURY. THE LOT NUMBER OF BACLOFEN, TYPE, DOSE AND CONCENTRATION WERE ASKED BUT REPORTED AS UNKNOWN. IT WAS REPORTED THAT THE PATIENT¿S PUMP HAD ALARMED OR BEEPED BACK IN (B)(6) 2015. THERE WAS EXPRESSED CONCERN ABOUT THE STANDARD OF CARE IN OTHER COUNTRIES. THE PATIENT HAD SEVERAL PREVIOUS REFILLS IN (B)(6). HOWEVER, THE CALLER STATED SHE HAD TO DO EVERYTHING INCLUDING CALL THE HEALTH CARE PROVIDER, CALL THE TECHNICIAN, CALL THE PHARMACY, ETC. ONE TIME THE TECHNICIAN DID NOT HAVE A REFILL KIT AND THEY COULD NOT GET IT IN TIME AND THE ALARM ON THE PUMP WENT OFF. THE PATIENT HAD NO SYMPTOMS. REPORTEDLY IT WAS A ¿REAL HASSLE¿ TO GET A REFILL OVERSEAS. THE CALLER STATED SHE WAS IN CHARGE OF THE CARE IN (B)(6) AND IF SHE DID NOT DO ANYTHING THE PUMP WOULD NOT HAVE GOTTEN FILLED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING STATUS OF THE PUMP RESERVOIR, RESOLUTION TO THE EVENT BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER ON 2016-02-16 IN WHICH IT WAS REPORTED THAT THE ALARM WAS NOT CONFIRMED TO BE DUE TO AN EMPTY PUMP. NO ACTIONS OR INTERVENTIONS WERE TAKEN TO RESOLVE THE ALARM AND THE ISSUE WAS NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63942 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR