BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202393 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04709
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    April 4, 2012
    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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(40, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT¿S CATHETER WAS REPLACED THEY COULD NOT GET THE ENTIRE OLD CATHETER OUT. PART OF THE OLD CATHETER REMAINED IN THE INTRATHECAL SPACE. 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
    301971 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other