BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3161470 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-02779
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 12, 2013
    Report Date
    May 14, 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. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED FOR LOW BACK AND RIGHT LEG PAIN. IT WAS REPORTED THE PT ONLY FELT STIMULATION IN HIS LEFT LEG AFTER HE SAT DOWN. REPROGRAMMING WAS UNABLE TO RECAPTURE EFFECTIVE STIMULATION COVERAGE. X-RAYS REVEALED THE LEAD HAD MIGRATED. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248932 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3965256

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS LEAD: MODEL 3163| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)