BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3770567 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08064
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN INFLAMMATORY MASS/GRANULOMA AT THE CATHETER TIP. A REVISION WAS DONE IN WHICH THE CATHETER WAS PULLED DOWN 3 CENTIMETERS. THE DRUG DELIVERED BY THE SYSTEM WAS UNKNOWN AT THE TIME OF THE REPORT. THE PUMP WAS FILLED WITH SALINE AND CHRONIC PAIN RETURNED. THE PATIENT EXPERIENCED PAIN AT THE CATHETER TRACK. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE- NO INJURY.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DRUG AND CONCENTRATION BEING DELIVERED WERE UNKNOWN AS SALINE WAS IN THE PUMP WHE N THE MANUFACTURER'S REPRESENTATIVE INTERROGATED IT. NO FURTHER TROUBLESHOOTING ACTIONS WERE REPORTEDLY TAKEN, THE CAUSE OF THE GRANULOMA WAS NOT DETERMINED, AND THE RESOLUTION OF THE ISSUE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250017 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention