BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4776030 · Received May 15, 2015

    Report

    Report Number
    3004209178-2015-09245
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Report Date
    April 24, 2015
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT THE PATIENT NO LONGER HAD CONCERNS WITH THE DEVICE/THERAPY.

    Description of Event or Problem · 1

    (B)(6) 2015 CRTS 3231845 (CON): IT WAS REPORTED THE PATIENT WAS RECEIVING INTRATHECAL CLONIDINE AND PRIALT THERAPY. HER PRIALT MEDICATION WAS ¿MAXED OUT¿ IN THE STATE OF (B)(6). IN (B)(6) 2014, THE PATIENT¿S PUMP WENT EMPTY BECAUSE SHE COULD NOT FIND A HEALTH CARE PROVIDER (HCP) TO REFILL HER PUMP. THE PATIENT WENT THROUGH WITHDRAWAL WHILE TRYING TO FIND A PHYSICIAN. THE PATIENT VISITED THE VETERANS AFFAIRS (VA) EMERGENCY ROOM (ER) EVERY DAY FOR TWO WEEKS IN (B)(6) 2014. IN THE ER, SHE WAS GIVEN A DAILY INJECTION OF FENTANYL. SHE WOULD RETURN THE NEXT MORNING AND RECEIVE ANOTHER DAILY INJECTION OF FENTANYL. ONCE THE VA FOUND A PHYSICIAN TO REFILL THE PRIALT, THEY DECIDED TO SWITCH THE MEDICATION IN THE PUMP TO FENTANYL BECAUSE IT WAS MORE WIDELY DISTRIBUTED. NOW THAT THE PATIENT HAD BEEN SWITCHED TO FENTANYL, SHE WAS ABLE TO EXERCISE, PLAY FOOTBALL, AND DO MORE THINGS WITH HER KIDS. (THERE WAS ADDITIONAL INFORMATION REPORTED THAT WAS NOT RELEVANT TO THIS EVENT AND THEREFORE WAS OMITTED; SEE (B)(4) - PTM TURNING OFF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320342 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR