BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 2181270 · Received July 8, 2011

    Report

    Report Number
    1627487-2011-02883
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 11, 2011
    Manufacturer
    ST JUDE MED - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MED HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MED HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S LEAD WAS EXHIBITING LOW IMPEDANCE FOLLOWING THE IMPLANT PROCEDURE. THE PT REPORTED ADEQUATE STIMULATION. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SPINAL CORD STIMULATION LEAD LGW ST JUDE MED - NEUROMODULATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other