BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3862812 · Received May 23, 2014

    Report

    Report Number
    1627487-2014-23342
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    IT WAS REPORTED THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION COVERAGE. THE PT IS FEELING STIMULATION ONLY ON HIS LEFT SIDE. THE PT IS WITHOUT STIMULATION ON HIS RIGHT SIDE. IT WAS ALSO REPORTED THE PT'S RIGHT LEAD HAD MIGRATED. SURGICAL IS PENDING TO ADDRESS THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309176 OCTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3186 4424815

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other SCS IPG: MODEL 3788| SCS LEAD: MODEL 3286| IMPLANT DATE:| IMPLANT DATE: