BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3031960 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-15416
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-15417. THE PT WAS IMPLANTED WITH TWO LEADS (FROM DIFFERENT LOTS) ARE PART OF HER SCS SYSTEM. IT WAS REPORTED THE PT WAS EXPERIENCING INEFFECTIVE STIMULATION COVERAGE ON HER RIGHT SIDE. X-RAYS WERE TAKEN AND INDICATED ONE OF THE LEADS HAD MIGRATED APPROX FIVE VERTEBRAL BODIES. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128716 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3189 3772365

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3688