BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3873180 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11598
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 22, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 85 96SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STARTED HAVING WITHDRAWALS APPROXIMATELY A HALF A YEAR AGO. SPECIFIC VALUES WERE NOT PROVIDED BUT REPORTEDLY THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME. THIS HAD NOT BEEN THE FIRST REFILL POST IMPLANT. THE HEALTH CARE PROVIDER (HCP) ATTEMPTED A DYE STUDY 2-3 WEEKS PRIOR TO THE DATE OF THIS REPORT BUT WAS UNABLE TO GET THE DRUG OUT IN ORDER TO PUT THE DYE IN. REPORTEDLY, THE HCP SUSPECTED A KINK IN THE CATHETER. THE DEVICE SYSTEM CURRENTLY DELIVERED SUFENTANIL AND BUPIVACAINE. IT WAS NOT KNOWN WHAT MEDICATION THE DEVICE SYSTEM DELIVERED WHEN THE PATIENT STARTED HAVING WITHDRAWALS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350368 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR