BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3941541 · Received July 17, 2014

    Report

    Report Number
    3007566237-2014-01997
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS AND LOSS OF EFFECT. A DYE STUDY WAS ATTEMPTED BUT THERE WAS THE INABILITY TO ASPIRATE THE CATHETER AS A "BLOOD CLOTH" WAS FOUND IN THE CATHETER CONNECTION OR CATHETER ACCESS PORT (CAP). THIS REQUIRED THE EXPLANT AND REPLACEMENT OF THE DEVICE WITH THE DATE REPORTED APPROXIMATELY (B)(6) 2014. IT WAS REPORTED AS ¿UNKNOWN-N/A¿ IF THE ISSUE WAS RESOLVED OR THE CAUSE OF THE ISSUE DETERMINED. AT THE TIME OF THE EVENT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. THE PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED. THIS DEVICE SYSTEM DELIVERED LIORESAL. 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
    420140 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention