BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2934481 · Received January 28, 2013

    Report

    Report Number
    1627487-2013-12116
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 PHYSICIAN PLANS TO EXPLANT AND REPLACE THE PATIENT'S OCCIPITAL LEADS (OFF-LABEL USE). THE REASON FOR THE EXPLANT IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38037 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 33896

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS EXTENSIONS, MODEL 3346| IMPLANT DATE:| SCS IPG, MODEL, 3788| IMPLANT DATE: