BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3082349 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-01448
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 27, 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
    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. REFERENCE MFR REPORT: 1627487-2013-1447. IT WAS REPORTED THE PATIENT EXPERIENCED A BURNING SENSATION IN HIS BACK AT HIS LEAD SITE AFTER SUFFERING A FALL. THE PATIENT WENT TO THE ER FOR EVALUATION OF THE PAIN. THE PATIENT'S STIMULATION WAS TURNED OFF AND X-RAYS WERE TAKEN. THE PAIN SUBSIDED AFTER TURNING OFF THE STIMULATION. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND LEAD DIAGNOSTICS WERE GOOD. REPROGRAMMING WAS ABLE TO PROVIDE EFFECTIVE STIMULATION. THE PATIENT IS PENDING FOLLOW UP WITH HIS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164161 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3554441

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788