BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2033535 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-02361
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-02360. THE PATIENT RECEIVED AN SCS SYSTEM, INCLUDING TWO LEADS. IT WAS REPORTED THE ENTIRE SCS SYSTEM WAS EXPLANTED AND NOT IMMEDIATELY REPLACED DUE TO PAIN IN THE PATIENT'S CHEST WALL. ONCE THE SCS SYSTEM WAS REMOVED, THE PATIENT'S PAIN SUBSIDED. THE EXPLANT DATE WAS NOT AVAILABLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 65605

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention