BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3965809 · Received July 30, 2014

    Report

    Report Number
    3004209178-2014-13655
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT # N152935, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    THE HCP REPORTED AT PUMP REPLACEMENT ABOUT 3 MONTHS AGO, THEY DISCOVERED THAT THERE WAS A PROBLEM WITH THE CATHETER SO THEY PROGRAMMED THE PUMP TO MINIMUM RATE MODE SINCE THEY BELIEVE THE PATIENT WAS NOT GETTING THE MEDICATION. THE HCP DID NOT HAVE THE DETAILS AT THE TIME OF THE REPORT OF THE CATHETER PROBLEM AT THE TIME OF IMPLANT. THIS WAS THE FIRST REFILL SINCE THE PUMP EXCHANGE AND THE HCP WANTED TO PROGRAM A BRIDGE BOLUS BUT THE LOWEST DOSE THE PUMP WILL ALLOW FOR THE BRIDGE BOLUS WAS TOO HIGH. THE PATIENT WAS DOING WELL IN MINIMUM RATE MODE AND OPTIONS WERE REVIEWED. THE HCP STATED THEY WOULD LET THE PUMP RUN AND BRING PATIENT BACK. THE PUMP WAS USED TO DELIVER HYDROMORPHONE AND BUPIVICAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445183 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR