BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3810520 · Received May 6, 2014

    Report

    Report Number
    1627487-2014-03314
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 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 INFO 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 3 OF 3. REFERENCE MFR REPORTS: 1627487-2014-03312 & 1627487-2014-03313. THE PT HAS 6 SUPRAORBITAL SCS LEADS (OFF-LABEL), 4 OF WHICH HAVE THE SAME LOT NUMBER (MODEL 3166). IT WAS REPORTED, THE PATIENT EXPERIENCED LOSS OF STIMULATION. X-RAYS IDENTIFIED 3 OF THE SCS LEADS HAD MIGRATED (UNK WHICH LOT NUMBERS). THE SCS LEADS WERE REPOSITIONED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271149 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL- NEUROMODULATION 3189 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other SCS IPG: MODEL 3716 (2)| IMPLANT DATE: