BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2010742 · Received March 2, 2011

    Report

    Report Number
    1627487-2011-01193
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S EVALUATION: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF LEAD MIGRATION COULD NOT BE CONFIRMED VIA LABORATORY TESTING. SJM HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT REC'D HIS SCS SYSTEM, INCLUDING AN IPG AND A PERCUTANEOUS LEAD, ON (B)(6) 2010 FOR LOWER BACK AND BILATERAL LEG PAIN. IT WAS REPORTED THAT THE PT LOST STIMULATION TO THE RIGHT SIDE. AN X-RAY SHOWED THE LEAD HAD MIGRATED PARTIALLY OUT OF THE EPIDURAL SPACE. ON (B)(6) 2011, THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD SINCE IT WAS ALLEGEDLY UNABLE TO BE ADVANCED BACK INTO THE EPIDURAL SPACE. THE EXPLANTED LEAD WAS RETURNED TO THE MFR FOR ANALYSIS. FOLLOW UP ON THE PT FOUND THAT STIMULATION WAS CAPTURED POSTOPERATIVE AND NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 3185461

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention