BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4163529 · Received October 10, 2014

    Report

    Report Number
    3007566237-2014-02922
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT # N495134, IMPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDERS (HCP) GOT 17CC OF STERILE WATER OUT OF THE RESERVOIR BUT WERE UNABLE TO FILL THE RESERVOIR WITH THE FULL AMOUNT OF INTENDED DRUG. IT WAS THOUGHT THAT THE OPERATING ROOM (OR) NURSE HAD FILLED THE RESERVOIR TOO FAST AND THAT WAS WHY THEY WERE HAVING ISSUES. NO SYMPTOMS WERE REPORTED. (NO INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE OCCURRED PRIOR TO IMPLANT. IT WAS STATED THAT THE SURGICAL TECHNICIAN FILLED THE PUMP TOO QUICKLY AND ENGAGED THE PRESSURE LOCK. IT WAS SUGGESTED TO ADD BACK PRESSURE TO RELEASE THE LOCK. THE BACK PRESSURE WAS APPLIED AND THE PUMP WAS ABLE TO BE FILLED PRIOR TO IMPLANT. THE PATIENT HAD NO ISSUES AND WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639110 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR