BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2933716 · Received January 29, 2013

    Report

    Report Number
    3004209178-2013-01090
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8731SC LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HALLUCINATIONS. THE PATIENT COMPLAINED OF "BUGS AND WORMS CRAWLING IN THE EYES." AN EXAMINATION AND DECREASE IN DAILY DOSE WAS DONE. THE SEVERITY OF THE EVENT WAS MILD. THE PATIENT RECOVERED WITHOUT SEQUELAE. HOWEVER, ON THE SAME DAY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF HALLUCINATIONS INVOLVING "WORMS CRAWLING IN THE EYES." THE SEVERITY OF THE EVENT WAS MODERATE. A REDUCTION OF DAILY DOSE WAS DONE WITH A CHANGE IN MEDICATION TO DILAUDID. THE EVENTS WERE POSSIBLY RELATED TO THE DRUG, POSSIBLY RELATED TO THE DEVICE OR THERAPY, AND NOT RELATED TO THE IMPLANT PROCEDURE. THIS WAS AN ONGOING EVENT. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS NOTED TO HAVE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39368 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Other