BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4252632 · Received November 5, 2014

    Report

    Report Number
    1627487-2014-20401
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    August 24, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ST JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4). SJM HAS LIMITED INFORMATION 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#: 1627487-2014-20402. THE PT HAS TWO PERIPHERAL (OFF-LABEL) LEADS. IT IS UNK WHICH ONE IS RELATED TO THE ISSUE. THEREFORE, BOTH ARE BEING REPORTED. IT WAS REPORTED THE PT WAS EXPERIENCING BURNING AND ITCHING SENSATION WITH STIMULATION AT THE LEAD SITE OF HER PERIPHERAL SYS. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710337 OCTRODE SCS LEAD GZB ST JUDE MED - NEUROMODULATION 3189 3787675

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788| SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE: