BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3193105 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10968
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    April 5, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED SIDE EFFECTS OF PRIALT. THE PATIENT SYMPTOMS WERE SEVERE MOOD SWINGS, SEDATION, HALLUCINATIONS, MIGRAINE HEADACHES, MEMORY PROBLEMS, AND CONCENTRATION PROBLEMS. THE SEVERITY WAS INDICATED AS MODERATE. THE ETIOLOGY WAS INDICATED AS POSSIBLY RELATED TO THE DRUG ACTION; NO CHANGE IN DRUG; RELATED TO DEVICE OR THERAPY, POSSIBLY RELATED TO DEVICE OR THERAPY. NO DIAGNOSTICS WERE DONE. INTERVENTION WAS TO SUSPEND THERAPY AND SALINE USED, (B)(6) 2013. THE PATIENT OUTCOME WAS RESOLVED WITHOUT SEQUELAE (B)(6) 2013. IT WAS LATER REPORTED THAT PRIALT WAS STARTED (B)(6) 2013 AT 2MCG/DAY (0.083MCG/HR). PRIALT DOSE AT TIME OF EVENT WAS ALSO 2MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292935 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Other