BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1926415 · Received November 11, 2010

    Report

    Report Number
    3007566237-2010-09360
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN HAD DIFFICULTY WITH FILLING A PATIENT'S PUMP RESERVOIR. ASPIRATING THE RESERVOIR WAS ACCOMPLISHED, HOWEVER, THEY WERE UNABLE TO FILL IT. THE TUBING WAS DETERMINED TO BE PATENT. A LOCKED RESERVOIR VALVE PROCEDURE, WHILE USING A SMALLER SYRINGE FILLED WITH SALINE FOR GREATER PRESSURE WAS DISCUSSED/ADVISED. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN EXPOSED TO "HYPERBARIC OR SCUBA". THE OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1