BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032372 · Received March 28, 2011

    Report

    Report Number
    3007566237-2011-02340
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 11, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHARMACY DEPARTMENT MADE UP A CONCENTRATION OF 2000 UG/ML BACLOFEN AND LABELED IT AS 500 UG/ML. THIS DRUG WAS THEN USED TO PRIME AND FILL A NEWLY IMPLANTED PUMP. THE PT RECEIVED AN OVERDOSE OF BACLOFEN BECAUSE THE DOCTORS THOUGHT THEY WERE USING 500 UG/ML AS THIS IS WHAT DRUG WAS ORDERED. THE PT WAS MEDICALLY MANAGED. THE PUMP WAS SET TO MINIMUM RATE. THE HCP WAS PROVIDED EXPERT MEDICAL ADVICE WITH REGARDS TO MANAGING THE OVERDOSE. THE HCP WILL DO A RINSE OF THE PUMP RESERVOIR AND REFILL WITH THE LOWER CONCENTRATION OF DRUG WHEN THE PT IS STABLE. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention