BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3688982 · Received March 19, 2014

    Report

    Report Number
    3004209178-2014-04665
    Event Type
    Injury
    Date Received
    March 19, 2014
    Report Date
    February 26, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8590-1, LOT# N242817, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, RECENTLY, THE PATIENT HADN¿T ALWAYS FELT THE NUMBING SENSATION WHEN HE RECEIVED A PERSONAL THERAPY MANAGER (PTM) BOLUS. BASED ON LOGS, IT APPEARED THAT MOST OF THE PATIENT¿S BOLUSES WERE BEING DELIVERED. ON THE DAY OF THE REPORT, THE HEALTHCARE PROVIDER (HCP) PROGRAMMED A BOLUS EQUAL TO THE PATIENT¿S PTM BOLUS, AND HE FELT NUMBNESS AS EXPECTED. THE PATIENT FELT THAT, IN THE WEEK PRIOR TO THIS REPORT, IT STARTED TO WORK BETTER AGAIN. A DYE STUDY WAS BEING CONSIDERED. ON THE DAY OF THE REPORT, THE EXPECTED RESERVOIR VOLUME (ERV) WAS ABOUT 3ML AND THE ACTUAL RESERVOIR VOLUME (ARV) WAS ABOUT 5.8ML. AT THE PREVIOUS REFILL, THE VOLUMES WERE CLOSER. THE EVENT WAS TO BE DISCUSSED WITH THE HEALTHCARE PROVIDER (HCP) TO SEE IF HE WANTED TO TRY FURTHER TROUBLESHOOTING OR WAIT UNTIL THE NEXT REFILL TO SEE IF FURTHER VOLUME DISCREPANCIES OCCURRED, OR IF THE PATIENT REPORTED FURTHER INCONSISTENCIES WITH EXPECTED SENSATION FROM PTM BOLUSES. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND BUPIVACAINE. 2014 (B)(6) (COMM (B)(4)/HCP): IT WAS LATER REPORTED THAT THE REFILL BEFORE THE MOST RECENT REFILL HAD AN ERV OF 7.7ML AND AN ARV OF 9ML. AT THE TIME OF THIS REPORT, THE HCP WAS GOING TO RULE OUT A GRANULOMA. THE HCP WAS GOING TO SCHEDULE A DYE STUDY AND AN X-RAY OF THE THORACIC SPINE. IT WAS LATER REPORTED THAT A POSSIBLE CATHETER KINKING WAS QUESTIONED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THE NUMBNESS ASSOCIATED WITH THE PERSONAL THERAPY MANAGER (PTM) BOLUSES IS ADDRESSED IN A SEPARATE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161977 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other