BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3082329 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-12485
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 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 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

    IT WAS REPORTED THE PT EXPERIENCED A CHANGE IN THE STIMULATION. X-RAYS REVEALED THE LEADS HAD MOVED. THE PHYSICIAN REMOVED AND REPLACED THE LEADS. THE PT IS RECEIVING EFFECTIVE STIMULATION COVERAGE. NOTE THE PT RECEIVED TWO LEADS FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163270 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3806006

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE:| SCS EXTENSIONS: MODEL 3386 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHORS: MODEL 1192 (2)