BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3120516 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07910
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN: PRODUCT ID 8709, LOT# J11272R06, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS OBTUNDED AND WAS ADMITTED FOR A QUESTION OF OVERDOSE OF NARCOTICS. IT WAS BELIEVED IT WAS RELATED TO THE PUMP THERAPY. THE PUMP WAS INTERROGATED. THE LAST REFILL AND DOSE CHANGE WAS (B)(6) 2013. THE PHYSICIAN REDUCED THE DOSE IN HALF FROM 12.5 TO 6.5MG/DAY AND STOPPED THE ORAL MEDICATION. THE PHYSICIAN PLANNED TO PERFORM A CT. HCP ALSO REPORTED THE PATIENT FELL. IT WAS QUESTIONED IF SOMETHING WAS WRONG WITH THE PUMP. THE PATIENT WOULD BE DISCHARGED AS SOON AS HE WAS STABLE. THE PUMP WAS DELIVERING CLONIDINE, BUPIVACAINE AND MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221689 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization