BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850543 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-01358
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 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 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# 1627487-2014-01359. IT WAS REPORTED BOTH LEADS HAVE MIGRATED UP SEVERAL VERTEBRAE LEVELS AND AS A RESULT THE PT HAS PARTIAL STIMULATION. THE PT DENIES ANY TRAUMA OR FALLS. F/U REVEALED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 AND THE LEADS WERE RELOCATED BACK TO THE ORIGINAL LOCATION. EFFECTIVE STIMULATION WAS ACHIEVED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317180 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4424815

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other IMPLANT DATE:| SCS EXTENSION: MODEL 1772| IMPLANT DATE:| SCS IPG: MODEL 3788