BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2051071 · Received April 5, 2011

    Report

    Report Number
    1627487-2011-00458
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 27, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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 RECEIVED AN SCS SYSTEM INCLUDING AN IPG AND PERCUTANEOUS LEAD ON (B)(6) 2010. IT WAS REPORTED THAT A KNOT HAS DEVELOPED NEAR THE LEAD INCISION SITE. NEAR THE TIME OF THE REPORTED EVENT, THE PT WAS SAID TO HAVE PARTICIPATED IN STRENUOUS PHYSICAL ACTIVITY. THE IMPACTED AREA ALLEGEDLY FEELS IRRITATED WHEN THE PT'S STIMULATION IS IN USE, AND A PAINFUL SENSATION IS PRESENT WHEN THERAPY IS NOT IN USE. OTHERWISE, THE PT'S SCS SYSTEM IS REPORTEDLY OPERATING AS DESIGNED AND NO IMPEDANCE ISSUES HAVE BEEN OBSERVED. A CONSULTATION WITH THE PHYSICIAN WILL BE SCHEDULED TO DISCUSS A PLAN OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3186 3199503

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788