BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2190577 · Received July 25, 2011

    Report

    Report Number
    1627487-2011-06024
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL 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 MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PT'S LEFT LEAD WAS CAUSING DISCOMFORT WHEN THE AMPLITUDE FOR THE STIMULATION WAS INCREASED. IN AN EFFORT TO RESOLVE THIS MATTER, THE PHYSICIAN REPOSITIONED THE LEAD INCREASING THE IMPLANT DEPTH. FOLLOW-UP WITH THE PT FOUND THAT THE REPORTED ISSUE WAS RESOLVED AS A RESULT OF THE AFOREMENTIONED SURGICAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3240772

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT:| SCS IPG: MODEL UNKNOWN