BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3940466 · Received June 18, 2014

    Report

    Report Number
    1627487-2014-21406
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    October 16, 2013
    Report Date
    May 28, 2014
    Manufacturer
    ST JUDE MEDICAL - 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

    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. REFER TO MFR REPORT 1627487-2014-21405. THE PATIENT RECEIVED THREE PERIPHERAL (OFF-LABEL) LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT IS EXPERIENCING DISCOMFORT AT THE IPG SITE IN ADDITION TO INEFFECTIVE STIMULATION. THE PATIENT DOES NOT FEEL STIMULATION AT MAXIMUM AMPLITUDE AND AT TIMES IT IS POSITIONAL. REPROGRAMMING WAS UNSUCCESSFUL. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357770 OCTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3186 4097068

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SCS EXTENSION: MODEL 3383 (2),| IMPLANT DATE: