BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3905236 · Received July 1, 2014

    Report

    Report Number
    3004209178-2014-12328
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED OVER THE PAST WEEKEND, THE PATIENT HAD COMPLAINED OF INCREASED PAIN. THE PATIENT HAD AN MRI AND NO GRANULOMA WAS FOUND. THE HEALTHCARE PROFESSIONAL (HCP) DIAGNOSED "TRAVERSE MYELITIS." THERE WERE NO NEUROLOGICAL DEFICIT (I.E. BOWEL OR BLADDER ISSUES). THE AREA OF CONCERN WAS T-10 AND SWELLING APPEARED FROM T7-12. THERE WERE NO ALARMS OR VOLUME DISCREPANCIES. THE PUMP CONTAINED FENTANYL, CLONIDINE, BUPIVACAINE AND DILAUDID (HYDROMORPHONE). IT WAS FURTHER REPORTED THE PATIENT WAS HAVING INCREASED PAIN AND WEAKNESS IN THEIR LOWER EXTREMITIES. THE MANUFACTURER REPRESENTATIVE (REP) AND HCP WERE DOING A REVISION OF CATHETER TODAY WITH THE ASSISTANCE OF A NEUROSURGEON. THE SYMPTOMS WERE NOTED TO BE STILL THE SAME AND THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    ON (B)(6) 2014 INFORMATION WAS RECEIVED FROM A REPRESENTATIVE INDICATING THAT THE PUMP WAS TURNED TO MINIMUM RATE AND THE CATHETER WAS JUST SUBCUTANEOUSLY ATTACHED TO THE PUMP, BUT IT WAS NOT IN THE INTRATHECAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383168 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention