BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1090683 · Received August 1, 2008

    Report

    Report Number
    3004209178-2008-04599
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING PUMP AND CATHETER REPLACEMENT, THE PATIENT WAS GIVEN AN INITIAL BOLUS OF 100 MCG OF BACLOFEN AND .16 MG OF MORPHINE. PRIOR TO SURGERY, THE PATIENT WAS RECEIVING BACLOFEN 3000 MCG/ML 500 MCG/DAY AND MORPHINE 5 MCG 0.8 MG/DAY. AFTER REPLACEMENT, THE RATE WAS DECREASED TO A DAILY DOSE OF BACLOFEN 200 MCG AND MORPHINE .33 MG. THE PATIENT WAS SUBSEQUENTLY NOTED TO BE DIFFICULT TO AROUSE. WITHIN SEVERAL HOURS, THE PATIENT HAD A RESPIRATORY ARREST. THE PUMP RATE WAS DROPPED TO MINIMUM RATE. THE PATIENT WAS REPORTED TO BE OVERWEIGHT. THE PATIENT WAS DOING FINE THE FOLLOWING DAY AND DISCHARGED WAS PLANNED. THE PATIENT WAS PROGRAMMED TO RECEIVE A DAILY DOSE OF 140 MCG OF BACLOFEN. THE HCP BELIEVED THAT THE ISSUE WAS RELATED TO "EXCESS ANESTHESIA" AND THE DEVICE WAS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| R CATHETER MODEL 8709SC LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN