BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2983130 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03160
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 8709SC, SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ABOUT A WEEK AFTER A PUMP IMPLANT, THE PATIENT'S STARTING DOSE WAS "TOO MUCH" FOR THE PATIENT. THE PATIENT EXPERIENCED A FEELING OF DROWSINESS, AND THEIR PHYSICIAN WAS NOT SURE IF THAT WAS CAUSED BY THE PATIENT'S SLEEP APNEA OR THE DRUG, SO HE ELECTED TO "BACK OFF ON THE DRUG," AND THEY LOWERED THE PUMP TO A MINIMUM RATE. THE OLD DRUG CONCENTRATION OF 20MG/ML DILAUDID WAS GOING TO BE REMOVED AND REPLACED WITH A NEW, LOWER DRUG CONCENTRATION OF DILAUDID; HOWEVER, THE PATIENT'S PHYSICIAN REVIEWED THE BRIDGE BOLUS AND OPTED TO LEAVE THE CURRENT DRUG AND CURRENT CONCENTRATION AS IS. THE PATIENT WAS NOTED TO BE ON A STABLE DOSE AND BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87767 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention