BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2003932 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-02249
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 6 OF 7. REFERENCE MANUFACTURER REPORTS: 1627487-2011-02244, 1627487-2011-02245, 1627487-2011-02246, 1627487-2011-00247, 1627487-2011-02248 AND 1627487-2011-02250. THE PT HAD TWO SCS SYSTEMS, INCLUDING TWO IPGS, FOUR PERCUTANEOUS LEADS AND AN EXTENSION, IMPLANTED OCCIPITALLY FOR MIGRAINE HEADACHES (OFF-LABEL). IT WAS REPORTED THAT BOTH SYSTEMS WERE EXPLANTED AND NOT REPLACED DUE TO PAIN AT THE IMPLANT SITE. THE PT ALSO INDICATED THE STIMULATION WAS INADEQUATE AS SHE WAS EXPERIENCING BREAKTHROUGH PAIN. THE SCS PRODUCTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER, ANALYSIS IS CURRENTLY IN PROCESS. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES 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 3181 2770453

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention