BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2100610 · Received May 17, 2011

    Report

    Report Number
    1627487-2011-01533
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 HER SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2010 FOR LOW BACK AND BILATERAL LEG PAIN. IT WAS REPORTED THE PATIENT ONLY FELT STIMULATION ON ONE OF HER FIVE PROGRAMS. SHE STATED THAT SHE HAS SUDDENLY STARTED TO FEEL AN UNCOMFORTABLE SENSATION AT THE MIDDLE OF HER BACK AFTER SHE TURNS OFF STIMULATION AND LAYS DOWN. FOLLOW UP ON THE PATIENT FOUND THAT SHE WAS REPROGRAMMED AND REPORTED EFFECTIVE STIMULATION COVERAGE. IT WAS REPORTED THAT THE MID BACK PAIN MAY BE A CERVICAL ISSUE WHICH IS UNRELATED TO HER SCS SYSTEM. THE PHYSICIAN HAS ORDERED A CT MYELOGRAM TO INVESTIGATE THE ISSUE. 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 3126663

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS IPG, MODEL: 3788| IMPLANT:| IMPLANT:| SCS LEAD ANCHOR, MODEL: 1192