BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3811399 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08950
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: 2014 (B)(4); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CATHETER REVISION/REPLACEMENT (SEE MANUFACTURER¿S REPORT # 3004209178-2014-05821), THE PATIENT HAD A HEADACHE AND CSF (CEREBROSPINAL FLUID) LEAK. THE CSF LEAK WAS SURGICALLY REPAIRED. THE PATIENT STATUS WAS REPORTED AT ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS DELIVERING GABLOFEN (2000MCG/ML AT 350 MCG/DAY). THERE WAS NO ALLEGED PRODUCT ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291292 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention