BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3835721 · Received May 28, 2014

    Report

    Report Number
    3004209178-2014-09709
    Event Type
    Injury
    Date Received
    May 28, 2014
    Report Date
    May 6, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8703W, SERIAL# (B)(4), IMPLANTED: (B)(6) 1997, PRODUCT TYPE CATHETER; PRODUCT ID 8575, LOT# N061703, IMPLANTED: (B)(6) 2006, PRODUCT TYPE ACCESSORY; PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8590-9, LOT# N429354, IMPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY; PRODUCT ID 8703W, SERIAL# (B)(4), IMPLANTED: (B)(6) 1997, PRODUCT TYPE CATHETER; PRODUCT ID 8575, LOT# N061703, IMPLANTED: (B)(6) 2006, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH 18 ML OF FLUID IN IT, AND IT WAS RUNNING IN SIMPLE CONTINUOUS INFUSION MODE. VOLUME INFUSION TESTING WAS PERFORMED FOR EIGHT DAYS, AND THE PUMP PERFORMED AS DESIGNED. THE PUMP PASSED DISPENSE ACCURACY TESTING. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE CAUSE OF THE DISCREPANCIES WAS UNKNOWN. THE PATIENT HAS BEEN DOING WELL SINCE THE PUMP WAS REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PUMP WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERE HAD BEEN A CATHETER DYE STUDY DONE. IT WAS ALSO REPORTED THAT THEY WANTED THE PUMP REPLACED. THE REPORTER DIDN¿T KNOW IF THERE HAD BEEN DOSE INCREASES OR A PROGRAMMED SINGLE BOLUS DOSE SAFE FOR THE PATIENT TO CONFIRM PATIENT RESPONSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, SINCE THE PUMP REPLACEMENT APPROXIMATELY 14 MONTHS AGO, THERE HAD BEEN EXTRA RESIDUAL VOLUMES DURING REFILLS AND THE PATIENT EXPERIENCED LACK OF PAIN RELIEF. ONE DISCREPANCY HAD AN ACTUAL RESIDUAL VOLUME (ARV) OF APPROXIMATELY 10 ML AND AN EXPECTED RESIDUAL VOLUME (ERV) OF APPROXIMATELY 3 ML. IT WAS UNCLEAR WHEN THIS DISCREPANCY OCCURRED. IT TOOK MANY MONTHS TO GET THE APPROVAL TO REPLACE THE CATHETER, AND THEY WERE FINALLY ABLE TO DO SO APPROXIMATELY ONE MONTH PRIOR TO THE REPORT, AS THE HEALTHCARE PROVIDER (HCP) ASSUMED THAT THE PROBLEM WAS WITH THE CATHETER. HOWEVER, EVEN AFTER THE CATHETER REPLACEMENT, THE PATIENT CONTINUED TO HAVE THE SAME ISSUE WITH THE LACK OF PAIN RELIEF AND EXTRA RESIDUAL VOLUME IN THE RESERVOIR. THE HCP THEREFORE BELIEVED THAT THE PUMP WAS THE PROBLEM. IT WAS NOTED THAT THE HCP WAS ABLE TO EASILY ASPIRATE FROM THE CATHETER. IT WAS CONFIRMED THAT THERE WERE NO LOGS INDICATING A MOTOR STALL. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314448 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention