BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1910992 · Received November 23, 2010

    Report

    Report Number
    3004209178-2010-09893
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS REFILLED AND A BRIDGE BOLUS WAS NOT DONE. THE DRUG CONCENTRATION HAD BEEN 500 MCG/ML WITH 165 MCG/DAY; THE TYPE OF DRUG WAS NOT REPORTED. THE PUMP WAS REFILLED WITH 2000 MCG/ML, BUT LEFT PROGRAMMED TO 500 MCG/ML. THE PT STARTED HAVING OVERDOSE SYMPTOMS AND WAS ADMITTED TO HOSPITAL. AS OF (B)(6) 2010, THE PT WAS STILL HOSPITALIZED AND BEING MONITORED. THE PT WAS STARTING TO DO BETTER. HE WAS MORE AROUSABLE AND BREATHING ON HIS OWN. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| L CATHETER: MODEL 8709SC, LOT# N259871003| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840, SERIAL# UNK