BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD

    MDR report key: 2120966 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-02808
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-02809. THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT HAD LOST STIMULATION AND IT COULD NOT BE RECAPTURED VIA REPROGRAMMING. AN X-RAY SHOWED THAT ONE LEAD HAD MIGRATED. THE PATIENT ALSO STATED THAT THE IPG WAS DIFFICULT TO CHARGE AND UNCOMFORTABLE. THE LEAD AND IPG WERE EXPLANTED AND REPLACED ON (B)(6) 2011. EFFECTIVE STIMULATION WAS CAPTURED POSTOPERATIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE EXPLANTED PRODUCTS WERE NOT RELEASED BY THE FACILITY; THEREFORE, THEY WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 96890

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention