BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2260032 · Received August 26, 2011

    Report

    Report Number
    3007566237-2011-06944
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE SURGEON PULLED THE CATHETER OUT OF THE INTRATHECAL SPACE DURING A SURGERY NOT RELATED TO THE INFUSION SYSTEM. THE SURGEON WAS TO LEAVE THE CATHETER COILED UP AND HAVE IT REVISED AT A LATER DATE. IT WAS LATER INFORMED THAT THE "PUMP WAS NOT REINSERTED AND WILL BE RE-IMPLANTED AT A LATER DATE." PT SIGNS AND SYMPTOMS WERE NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N064448012