BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1870742 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07885
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    April 20, 2010
    Report Date
    April 20, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT HAD EXPERIENCED AN OVERDOSE. IT WAS STATED THAT THE PT'S PUMP DEVICE HAD PREVIOUSLY CONTAINED MORPHINE AND CLONIDINE AT 22.5MG/ML AT 7MG/DAY. THE PT'S PUMP WAS REFILLED WITH MORPHINE AND CLONIDINE AT 50MG/ML A 7MG/DAY. IT WAS STATED THAT NO BRIDGE BOLUS WAS PROGRAMMED IN TO THE PT'S PUMP. IT WAS STATED THAT, THIRTY MINS AFTER THE PUMP HAD BEEN REFILLED, THE PT LOST CONSCIOUSNESS AND EXPERIENCED RESPIRATORY DEPRESSION. THE PT WAS THEN ADMITTED TO THE EMERGENCY ROOM AND REPORTEDLY RESPONDED TO "A NARCAN DRIP AFTER SEVERAL DOSES." IT WAS STATED, THE PT WAS IN "SERIOUS CONDITION." ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L 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 55 YR Hospitalization| R IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N179642006| ACCESSORY: MODEL 8590-1, LOT# N160001| EXPLANTED:| IMPLANTED: