BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3221612 · Received July 9, 2013

    Report

    Report Number
    1627487-2013-12914
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2013-12913. IT WAS REPORTED THE PATIENT'S LEFT LEAD MIGRATED AND STIMULATION WAS LOST. THE PHYSICIAN REMOVED AND REPLACED THE LEAD. THE PATIENT WAS IMPLANTED WITH TWO OCTRODE LEADS FROM TWO LOT NUMBERS. IT IS UNKNOWN WHICH LEAD WAS EXPLANTED, THEREFORE, BOTH LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313593 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3904347

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other SCS ANCHORS, MODEL 1192 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE: