BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2143086 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-02850
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 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

    THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. X-RAYS REVEALED THAT THE LEAD HAD MIGRATED. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2011. THE EXPLANTED LEAD WAS DISCARDED; THEREFORE, IT WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER PATIENT COMPLICATIONS WERE 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 3186 115788

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SCS IPG: MODEL 3716| IMPLANTED: