BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2080255 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-02410
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 MANUFACTURER REPORT: 1627487-2011-02411. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2007. IT WAS REPORTED THE PATIENT'S STIMULATION WAS VARYING AND INTERMITTENT. REPROGRAMMING WAS NOT ABLE TO RESOLVE THE ISSUE. THE PATIENT WAS REFERRED FOR FURTHER TESTING (X-RAY, DIAGNOSTIC LEAD TESTING, ETC). SHE IS REPORTEDLY WORKING WITH HER PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION. 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 86627

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention