BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3001462 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-01264
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    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 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

    IT WAS REPORTED THE PATIENT'S TRIAL LEAD WAS PREMATURELY REMOVED DUE TO PERSISTENT PAIN IN HIS UPPER BACK. THE TRIAL LEAD INITIALLY PROVIDED GOOD STIMULATION IN THE LOW BACK AND LEGS. RESISTANCE WAS ENCOUNTERED AT T9/T10 AND THE LEAD WAS BENT INTO A QUESTION MARK SHAPE WHEN THE PHYSICIAN TRIED TO ADVANCE DURING IMPLANT SURGERY. THE LEAD WAS PULLED BACK AND LEFT AT T9. THE PATIENT DID COMPLAIN OF PAIN IN THEIR UPPER BACK POST-OPERATIVELY. THE PAIN GOT PROGRESSIVELY WORSE THROUGH THE TRIAL AND THE PATIENT WAS ADVISED TO GO TO THE ER ON (B)(6) 2013 WHERE THE LEAD WAS EXPLANTED. IT WAS NOTED THERE ARE EXPOSED WIRES AROUND CONTACT 2 OF THE LEAD. THE PATIENT'S ISSUE OF PAIN IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94157 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 3832021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention