BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2171011 · Received June 30, 2011

    Report

    Report Number
    3007566237-2011-04976
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER HAD DISLODGED AND BACKED OUT OF THE INTRATHECAL SPACE. THEY WERE CONSIDERING REVISION OF THE CATHETER AS WELL AS OF THE PUMP. "THE PUMP WAS TO BE MOVED IN POCKET TO MORE COMFORTABLE LOCATION." NO INFO WAS AVAILABLE ON PT STATUS, LAB TESTS AND DRUGS INFUSED VIA THE PUMP. ADDITIONAL INFO 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
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-40| LOT# NGV446215H| EXPLANTED: