BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3122042 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07964
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 23, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N311508, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HIS PUMP REFILLED AND HIS DOSE INCREASED THE PREVIOUS WEEK. THE PATIENT HAD BEEN SICK AND WAS IN THE HOSPITAL ON (B)(6) 2013. IT WAS INDICATED THE PUMP WAS SHUT OFF ACCIDENTALLY WHEN AN EKG WAS DONE. IT WAS NOTED ¿THEY SHUT EVERYTHING OFF FOR A LONG TIME¿. SINCE THE MEDICATION WAS INCREASED THE PATIENT EXPERIENCED NAUSEA, SORE THROAT, HAD A ¿TERRIBLE TASTE--IT¿S JUST LIKE ANESTHESIA¿, THEIR ¿NOSE IS BURNING OFF AND ON¿ AND WAS NOT ¿FEELING RIGHT¿. THE PATIENT HAD BACK PAIN. THE PATIENT WAS GETTING ¿FUMES FROM IT¿ OR ¿DIFFERENT SMELLS¿. THE PATIENT CONTACTED THE HCP AND WAS TOLD IT WASN'T POSSIBLE THAT IT WAS RELATED TO THE MEDICATION. THE PATIENT PLANNED TO CONTACT THEIR PHYSICIAN THE NEXT DAY. A MYLEOGRAM WAS PLANNED. THE PATIENT WAS TAKING ORAL HYDROMORPHONE AND THE DOSAGE HAS BEEN THE SAME FOR SOME TIME. THE PUMP WAS DELIVERING FENTANYL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224278 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization