BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3112506 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07668
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 16, 2013
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# SERIAL# (B)(4),IMPLANTED: 2003 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8578 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8578 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN IN MORE PAIN. ON THE DAY OF REPORT, THE PATIENT WAS HAVING A "BAD DAY WITH PAIN". HER PAIN WAS LOCATED IN HER BACK. THE DEVICE SYSTEM WAS INFUSING MORPHINE AND AN UNKNOWN DRUG. IT WAS STATED THAT THE PATIENT WAS "AT MAX" WITH WHAT COULD BE DONE WITH MORPHINE, BUT NOTED THAT MORPHINE WAS THE ONLY DRUG THAT HAD GIVEN HER ANY RELIEF. IT WAS LATER REPORTED THAT THE EVENT WAS DUE TO UNKNOWN "PROBLEMS" WITH THE INTRATHECAL CATHETER. THE HEALTHCARE PROVIDER (HCP) PERFORMED A SIDE PORT STUDY WHICH SHOWED PROBLEMS WITH THE CATHETER. THE HCP NOTED THAT THE PATIENT WOULD NEED A REVISION. THE DEVICE SYSTEM ALSO DELIVERED BUPIVACAINE. IT WAS LATER REPORTED THAT THE PATIENT WAS AWAITING REVISION OF HER INTRATHECAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213185 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention