BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3810184 · Received May 14, 2014

    Report

    Report Number
    3004209178-2014-08942
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    March 29, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8782, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8784, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 FOR A SUSPECTED VP (VENTRICULOPERITONEAL) SHUNT INFECTION AND REMOVAL OF VP SYSTEM. IT WAS DETERMINED THAT THE PATIENT HAD A CSF (CEREBROSPINAL FLUID) INFECTION. THEY DECIDED TO REMOVE THE SPINAL SEGMENT OF THE CATHETER DUE TO THE CSF INFECTION. THE PATIENT WAS BEING TREATED FOR MENINGITIS. THE DEVICE SYSTEM WAS DELIVERING GABLOFEN (2000 MCG/ML AT 1180 MCG/DAY). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. (B)(4). NO NEW INFORMATION REGARDING EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288541 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Hospitalization| R