BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4221677 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20876
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8590-1, LOT# N229898, IMPLANTED: 2009 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A FILLING DIFFICULTY WAS REPORTED. THE PATIENT REPORTED OVERDOSE SYMPTOMS IMMEDIATELY UPON NORMAL REFILL WITHOUT A CHANGE IN DOSE OR CONCENTRATION. SYMPTOMS INCLUDED ALTERED MENTAL STATUS, SHAKING, DIZZINESS, AND LIGHTHEADEDNESS. DRUG MAY HAVE LEAKED FROM THE NEEDLE INTO THE POCKET, OR AN INFUSION OF DRUG FROM THE CATHETER MAY HAVE ENTERED AFTER THE FILL WAS COMPLETED. THEY WERE NOT SURE IF A POCKET FILL WAS PERFORMED AS ALL MEDICATION WAS ACCOUNTED FOR. THE PATIENT WAS GIVEN NARCAN AND WAS MONITORED FOR AN HOUR OR SO. THEY RECOVERED WITHOUT ISSUE, AND THE PATIENT WAS DOING FINE. THE PUMP CONTAINED FENTANYL AND BUPIVACAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTH CARE PROVIDER (HCP) OFFICE WAS CHANGING THEIR TECHNIQUE AFTER BEING RE-TRAINED BY THE DEVICE MANUFACTURER REPRESENTATIVE. THE OFFICE ALSO CHANGED THEIR POLICY SO THAT ALL PATIENTS HAVE TO WAIT FOR 1 HOUR BEFORE LEAVING THE OFFICE AFTER A REFILL TO MONITOR FOR SIDE EFFECTS. THE CAUSE OF ISSUE WAS TECHNIQUE; THERE WERE NO ISSUES WITH THE REFILL KIT. THE OFFICE WAS ALSO GOING TO START USING ULTRASOUND TO HELP WITH NEEDLE PLACEMENT DURING REFILLS AS WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703169 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention