BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2033486 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-00403
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT TESTING WAS NOT PERFORMED AS THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED THROUGH SUCH MEANS. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00404. THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2010, INCLUDING TWO PERCUTANEOUS LEADS AND TWO LEAD ANCHORS FOR LEFT ARM PAIN. IT WAS REPORTED THAT THE LEADS AND ANCHORS WERE REPLACED DUE TO LEAD MIGRATION. EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT FOLLOWING THE PROCEDURE.

    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 DIVISION 3186 2844803

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention