BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2120958 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-00805
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 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 AN SCS SYSTEM ON (B)(6) 2003 INCLUDING A PERCUTANEOUS LEAD. IT WAS REPORTED THAT HE LOST STIMULATION. THERAPY WAS RECAPTURED FOR THE PATIENT BY ADJUSTING THE AMPLITUDE FOR HIS SET PROGRAM; HOWEVER, THE RESULTING COVERAGE WAS INADEQUATE. A DIAGNOSTIC TEST DID NOT REVEAL ANY IMPEDANCE ISSUES NOR DID AN X-RAY SHOW ABNORMALITIES WITH RESPECT TO LEAD POSITION. THE PATIENT UNDERWENT A TRIAL LEAD PLACEMENT ON (B)(6) 2011, AND IT WAS REPORTED THAT ADEQUATE THERAPY COVERAGE WAS OBTAINED AS A RESULT. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADD A NEW LEAD TO THE PATIENT'S CURRENT SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 18730

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS IPG: MODEL 3688| IMPLANTED: