BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2871802 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11796
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT SUDDENLY EXPERIENCED OVERDOSE SYMPTOMS DESCRIBED AS A DEPRESSED LEVEL OF CONSCIOUSNESS AND RESPIRATORY ARREST. THE PATIENT WAS HOSPITALIZED. DIAGNOSTIC TESTING/TROUBLESHOOTING WAS PERFORMED, REPROGRAMMING, MRI, X-RAY, AND AN INFECTION TEST TO DETERMINE THE CAUSE OF THE SYMPTOMS. THERE WERE NO ABNORMALITIES. AFTER DECREASING THE DAILY DOSE OF 825 UG/DAY TO A DAILY DOSE OF 411 UG/DAY, AT THE FIRST FOLLOW UP, THE PATIENT FELT BETTER ALREADY. THE PATIENT REMAINED IN THE HOSPITAL AND WAS ALIVE WITH INJURY. THE PUMP WAS DELIVERING LIORESAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Hospitalization| R