BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4062068 · Received September 4, 2014

    Report

    Report Number
    3004209178-2014-16419
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TRANSFERRED TO AN INTERMEDIARY CARE UNIT AFTER SURGERY AND THE TRANSFERRED TO AN INTENSIVE CARE UNIT LATER IN THE EVENING DUE TO SEIZURES, OVERDOSE SYMPTOMS AND INCREASED SPASTICITY. THE PUMP WAS STOPPED DURING THE NIGHT AND THE PHYSICIAN CAME THE NEXT MORNING AND RESTARTED THE PUMP AT HALF THE DAILY DOSE BECAUSE THE PATIENT HAD SHOWED WITHDRAWAL/UNDERDOSE SYMPTOMS. THE PUMP WAS PROGRAMMED TO MINIMUM RATE LATER AS THE PATIENT WAS NOT GETTING BETTER. THE PHYSICIAN THOUGHT THAT IT COULD BE AN ERROR OF MEDICATION IN THE PUMP. THE PUMP WAS SUSPECTED TO HAVE BEEN FILLED WITH XYLOCAINE BY ERROR. REPORTEDLY, IT WAS NOT A PRODUCT ISSUE, BUT WAS MOST LIKELY THAT THE SCRUBBED NURSE HAD TWO SIMILAR SYRINGES ON THE BACK TABLE, ONE FILLED WITH XYLOCAINE AND THE OTHER WAS FILLED WITH LIORESAL; NEITHER ONE WAS IDENTIFIED. SHE MIGHT HAVE TAKEN THE ONE FILLED WITH XYLOCAINE TO FILL THE PUMP INSTEAD OF BACLOFEN BUT THERE WAS NO EVIDENCE AT THAT TIME. A DIFFERENT ¿PRODUCT¿ WAS USED AS THE MEDICATION WAS CHANGED IN THE PUMP, THE PUMP TUBING WAS FLUSHED AND THE CATHETER WAS EMPTIED. THE PUMP REMAINS IMPLANTED AND IN-SERVICE. IT WAS UNKNOWN IF ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED. IT WAS NOT SPECIFIED IF THE ISSUE WAS RESOLVED OR THE CAUSE DETERMINED. THIS DEVICE SYSTEM DELIVERED LIORESAL. AN INQUIRY WAS MADE FOR THE PATIENT¿S CURRENT STATUS IN WHICH THE PATIENT WAS REPORTED TO STILL HAVING RESPIRATORY PROBLEMS SINCE POST-OP. THE PATIENT HAD A ¿ ROUGH WEEK-END AFTER HIS SURGERY¿ BUT WAS FEELING VERY GOOD THE NEXT MONDAY. THE DOSAGE WAS FIXED AND THE PATIENT WAS RECEIVING GOOD THERAPY. THE PATIENT WAS PREPARING FOR HOSPITAL DISCHARGE BUT WAS NOTED AGAIN TO SHOW RESPIRATORY PROBLEMS. TESTING OF THE MEDICATION THAT WAS INITIALLY USED TO FILL THE PUMP SHOWED NO EVIDENCE OF XYLOCAINE. THE PUMP WAS CORRECTLY FILLED WITH BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541672 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R