BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4060848 · Received August 6, 2014

    Report

    Report Number
    1627487-2014-06217
    Event Type
    Injury
    Date Received
    August 6, 2014
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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

    DEVICE 3 OF 3. REFERENCE MFR REPORT: 1627487-2014-06215 AND REFERENCE MFR REPORT: 1627487-2014-06216. IT WAS REPORTED THE PATIENT EXPERIENCED A SHARP BURNING, SHOCK-LIKE PAIN WHENEVER THE SCS IPG WAS OFF. THE PATIENT HAD UNBEARABLE PAIN IN HER BACK AT THE IMPLANT SITE WHENEVER SHE MOVED TO A SITTING POSITION AND THEN WHEN STANDING BACK UP. THE PATIENT REPORTED HER PHYSICIAN INDICATED IT WAS HER RSD INITIALLY, AND LATER THEY TOLD HER THE STIMULATOR WAS MOVING WHEN SHE MOVED. F/U INFO IDENTIFIED THE PATIENT WAS RECEIVING EFFECTIVE STIMULATION. THE PATIENT'S ENTIRE SCS SYSTEM REMOVED. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461571 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL, NEUROMODULATION 3186 3918814

    Patients

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