BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4163526 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19447
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS STILL UNKNOWN. THE PUMP WAS INTERROGATED AND NO ANOMALIES WERE FOUND. THE CATHETER WAS DETERMINED TO BE PATENT. THE DRUG WAS TESTED AND THE DRUG WAS DETERMINED TO BE CORRECT. THE PATIENT WAS CURRENTLY DOING FINE AND WAS RECEIVING EFFECTIVE THERAPY. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN THE ER (EMERGENCY ROOM) LAST NIGHT. THE PATIENT WAS IN A COMATOSE STATE PER HEALTHCARE PROFESSIONAL (HCP). IT WAS UNKNOWN WHEN THE SYMPTOMS STARTED AND IF THEY WERE GRADUAL/SUDDEN. THE PUMP WAS LAST REFILLED 8 DAYS PRIOR TO THIS REPORT. MENINGITIS WAS RULED OUT. THE HCP TOOK THE DRUG OUT OF THE RESERVOIR AND DILUTED IT IN HALF. THE HCP THEN ACCESS THE CAP (CATHETER ACCESS PORT) TO CLEAR THE CATHETER, BUT THE OLD DRUG WAS LEFT IN THE PUMP TUBING. THE HCP HAD REQUESTED THE OLD DRUG BE ANALYZED. THE PATIENT WAS ALIVE, WELL AND ALERT AT THE TIME OF THIS REPORT. THE PUMP WAS USED TO DELIVER CLONIDINE AND BACLOFEN (COMPOUNDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639109 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other