BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201633 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04562
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 25, 2012
    Report Date
    January 25, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CEREBROSPINAL FLUID (CSF) LEAK. THERE WAS A REVISION SURGERY. THE CATHETERS WERE REPLACED AND THE PATIENT WAS DOING ¿WELL¿ WITH EFFECTIVE THERAPY. THE DEVICES WOULD NOT BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303404 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention