BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3843801 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09975
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 13, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, LOT# N219255001, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER; PRODUCT ID 8 590-1, LOT# N232981, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. (B)(4). 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

    (B)(4). ANALYSIS OF THE PUMP REVEALED NO ANOMALY. ANALYSIS OF THE CATHETER REVEALED SC CONNECTOR CORING-TEARS-CUTS IN SEAL. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS REPORTED. THE EXPECTED RESIDUAL VOLUME 7ML AND THE ACTUAL RESIDUAL VOLUME 16ML. THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS, INCREASED PAIN. IT WAS UNKNOWN IF ANY DIAGNOSTICS OR TROUBLESHOOTING WAS PERFORMED. THE PUMP AND CATHETER WERE REPLACED. THE REPLACEMENT PUMP WAS FILLED WITH DILAUDID 5MG/ML AT A DOSE OF 0.5MG/DAY PER THE IMPLANTING HCP. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS INDICATED AS ALIVE, NO INJURY. THE PUMP WAS USED TO DELIVER DILAUDID. ADDITIONAL INFORMATION LATER REPORTED IT SEEMED TO BE AN ISSUE WITH THE SUTURELESS CONNECTOR AS THE SURGEON COULD NOT PUSH FLUID THROUGH WHEN EXAMINING AT THE END OF THE CASE. BOTH THE PUMP AND CATHETER PORTION THAT WAS EXPLANTED WERE BEING RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE HCP TRIED TO PUSH FLUID THROUGH AFTER IT WAS DISCONNECTED FROM THE PUMP. IT SEEMED TO BE OCCLUDED AS HE COULD NOT FLUSH THE SC PORTION OF THE CATHETER AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321647 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention