BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3242837 · Received July 23, 2013

    Report

    Report Number
    3007566237-2013-02450
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    February 15, 2008
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT # N088377, IMPLANTED: (B)(6) 2006, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HALLUCINATING AFTER LAST INCREASE IN PUMP REFILL, OVER THE PAST THREE DAYS. PATIENT WAS ADMITTED TO ER WITH PNEUMONIA AND CONFUSION. A PAIN SPECIALIST TURNED DOWN THE PUMP FROM 1.1 TO 0.8 WERE THERE WAS AN IMMEDIATE IMPROVEMENT AND THE CONFUSION/HALLUCINATIONS SEEMED TO STOP. IT WAS STATED THAT SINCE HIS DOSE OF CLONIDINE WAS OVER 100-MCG PER DAY THAT COULD BE WHAT CREATED THE CONFUSION, BUT STILL NOT SURE OF THE EXACT SOURCE OF THE CONFUSION/HALLUCINATIONS. PATIENT OUTCOME WAS NOTED AS RESOLVED WITHOUT SEQUELAE

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HALLUCINATION EVENT WAS ACTUALLY A PHONE CALL FROM THE PATIENT'S SPOUSE, NOT AN OFFICE VISIT, THUS THERE WAS NO TELEMETRY REPORT. THE PATIENT'S PUMP WAS TURNED DOWN AT THE HOSPITAL TO TRY TO RULE THE MEDICATION OUT. IT WAS NOTED THAT THE ACTUAL CAUSE WAS STILL UNCERTAIN. THE CLONIDINE IN THE PUMP THAT WAS TURNED DOWN WAS GRADUALLY, IN A PERIOD OF TIME, TURNED BACK UP WITHOUT COMPLICATIONS. THE REPORT PRIOR TO THE INCIDENCE NOTED THE MEDICATIONS WERE DILAUDID 2.0 MG/ML, BUPIVACAINE 5.0 MG/ML, AND CLONIDINE 200 MCG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343749 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R