BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4081916 · Received September 11, 2014

    Report

    Report Number
    3004209178-2014-16869
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO ALLEGED PRODUCT ISSUES AGAINST THE PUMP SYSTEM. THE PATIENT REPORTED DISCOMFORT NEAR THE PUMP LOCATION. A REVISION FOUND THE CATHETER CONNECTOR PLACEMENT WAS LOCATED IN A WAY THAT WAS IRRITATING THE PATIENT; SO A NEW CATHETER PIECE WAS ADDED AND THE POCKET LOCATION WAS ADJUSTED TO PROVIDE BETTER COMFORT FOR THE PATIENT. THE LOCATION OF THE CONNECTOR WAS "WEDGED FUNNY IN THE POCKET." IT WAS REPORTED THAT X-RAYS WERE DONE. THE PUMP SYSTEM WAS DELIVERING MORPHINE AND BUPIVACAINE. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS "ALIVE- NO INJURY." IT WAS REPORTED THAT THE REVISION RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560702 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention