BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3130579 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08200
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS INITIALLY IMPLANTED WITH THE PUMP THE TUESDAY PRIOR TO THE REPORT FOLLOWING A SUCCESSFUL TRIAL. BEGINNING SATURDAY NIGHT THE PATIENT HAD HALLUCINATIONS, WENT TO BED, AND THEN WOKE UP FINE. THE PATIENT THEN STARTED HAVING HALLUCINATIONS SUNDAY NIGHT AND WOKE UP ON THE DAY OF THE REPORT STILL WITH HALLUCINATION. THE CALLER STATED THAT THE PATIENT WAS ON A VERY LOW DOSE. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL 250MCG/ML AT 12MCG/DAY. IT WAS LATER REPORTED THAT THE PATIENT'S HEALTHCARE PROVIDER (HCP) RECOMMENDED THAT THE PATIENT STOP HER ORAL BACLOFEN. THE REPORTER THOUGHT THIS WAS A POSSIBLE REASON FOR THE HALLUCINATIONS. THE PATIENT WAS CURRENTLY ON HER WAY TO THE EMERGENCY ROOM (ER) WHERE THE PLAN WAS TO PROGRAM THE PUMP TO MINIMUM RATE MODE AND RESTART ORAL MEDICATION TO SEE OF THE HALLUCINATIONS WOULD SUBSIDE. IT WAS LATER REPORTED THAT THE HALLUCINATIONS WERE DETERMINED TO HAVE BEEN DUE TO COMPLETELY STOPPING THE PATIENT'S ORAL BACLOFEN. THE PATIENT'S ORAL BACLOFEN WAS RESUMED AND THE HALLUCINATIONS STOPPED. THE PATIENT WAS REPORTED TO HAVE BEEN FINE WITH NO FURTHER ISSUES PER THE PATIENT'S NEUROSURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231450 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Other