BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3231576 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-03963
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 3. REFERENCE MFR. REPORTS: 1627487-2013-03962 AND 1627487-2013-03964. IT WAS REPORTED DURING THE PT'S PERMANENT PROCEDURE THE SCS LEADS HAD TO BE REPOSITIONED MULTIPLE TIMES TO RESOLVE HIGH IMPEDANCE ISSUES WHICH OCCURRED DUE TO THE PT'S LARGE ANATOMY. STIMULATION WAS EVENTUALLY ESTABLISHED IN THE PT'S PAIN PATTERN. FOLLOW-UP IDENTIFIED SINCE THE PROCEDURE THE PT HAD EXPERIENCED NAUSEA AS WELL AS HEADACHES WHICH OCCURRED REGARDLESS OF STIMULATION. THE HEADACHES DECREASED IN SEVERITY WITH TIME. ADDITIONALLY, AS OF (B)(6) 2013 BOTH THE NAUSEA AND HEADACHE ISSUES HAVE RESOLVED AND THE PT IS RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323796 OCTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3186 3965256

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: