BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4132974 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18103
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 8, 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

    CONCOMITANT PRODUCT: PRODUCT ID: 8578, SERIAL# N208141012, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, LOT# J10956R13, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECOVERED WITHIN 30 MINUTES AND THERE WERE NO OTHER ISSUES. IT WAS NOTED THE CLINIC WAS JUST BEING OVERLY CAUTIOUS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS FILLING DIFFICULTY DURING REFILL AND THE PATIENT REPORTED DIZZINESS, HEADACHE, OVERDOSE SYMPTOMS AND LIGHT HEADEDNESS IMMEDIATELY AFTER A NORMAL REFILL. IT WAS NOTED THE DRUG WAS ASPIRATED FROM THE PUMP AND MEASURED AND THERE WAS NO ABNORMALITY. THE CAUSE OF THE ISSUE WAS BELIEVED TO BE DUE TO THE REFILL TECHNIQUE AND SOME MEDICINE MAY HAVE LEAKED OUT FROM THE NEEDLE INTO THE SUBCUTANEOUS TISSUE. IT WAS ALSO REPORTED THE NURSE ACCIDENTALLY SPILLED 13-14 MILLILITERS (ML) OF DRUG ONTO PATIENT WHEN SHE WAS ASPIRATING DRUG TO MEASURE TO DETERMINE IF SOME HAD GONE INTO HER POCKET. THE PATIENT RESPONDED AND SEEMED NORMAL WITHIN 45 MINUTES AFTER REFILL. IT WAS REPORTED, ¿DO NOT THINK ANYTHING WAS DONE WRONG.¿ THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE-NO INJURY.¿ THE PATIENT WAS REFILLED AND GETTING EFFECTIVE THERAPY. THE BELIEF WAS THE PATIENT¿S LIGHTHEADEDNESS AND DIZZINESS WAS INDEPENDENT. THE PUMP WAS BEING USED TO DELIVER 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
    613312 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Other