BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2003933 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-01160
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE EVALUATION WAS NOT PERFORMED AS THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED BY PRODUCT TESTING. SJM HAS LIMITED INFORMATION 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 REC'D HER SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), ON (B)(6) 2010. IT WAS REPORTED THAT THE PT LOST STIMULATION. AN X-RAY CONFIRMED LEAD MIGRATION, AND THE PHYSICIAN EXPLANTED AND REPLACED THE LEADS ON (B)(6) 2011. THE PT DENIED HAVING ANY TRAUMATIC EVENTS OR FALLS THAT MAY HAVE CONTRIBUTED TO THE LEAD MIGRATION. THE EXPLANTED LEADS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. F/U ON THE PT FOUND THAT SHE REC'D EFFECTIVE STIMULATION AFTER THE REPLACEMENT PROCEDURE, 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 3131303

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention