BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4241989 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21274
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 20, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOR THE PREVIOUS 2-3 MONTHS, THE PATIENT HAD BEEN EXPERIENCING DECREASED THERAPY AND CHRONIC PAIN. CATHETER ASPIRATION WAS ATTEMPTED VIA THE CATHETER ACCESS PORT (CAP), AS THE PATIENT WAS ON A HIGH DOSE WITH MINIMAL THERAPY EFFECT. THE CAP WAS UNABLE TO BE ASPIRATED, AS THE HEALTHCARE PROVIDER (HCP) ¿ONLY GOT A BUBBLE¿. ON THE DATE OF THIS REPORT, THE PUMP WAS REFILLED AND THE HCP PLANNED TO REFER THE PATIENT TO NEUROSURGERY. THERE WERE NO ACTIVE PUMP ALARMS AND THE ACTUAL RESERVOIR VOLUME (ARV) WAS APPROXIMATELY WHAT WAS EXPECTED, AS THE ARV WAS 6.5ML AND THE EXPECTED RESERVOIR VOLUME (ERV) WAS 5.9ML. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN. THE FINAL PATIENT OUTCOME WAS NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722200 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR Required Intervention