BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3810720 · Received April 28, 2014

    Report

    Report Number
    1627487-2014-26357
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 26, 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 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 #1 OF 2. REFERENCE MFR REPORT: 1627487-2014-26358. THE PATIENT WAS IMPLANTED WITH TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. THE PHYSICIAN AGREED TO REPOSITION HER IPG. ON (B)(6) 2014, THE PATIENT WAS NO LONGER FEELING STIMULATION. THE IPG IS FULLY CHARGED AND WILL COMMUNICATED WITH EXTERNAL DEVICES; HOWEVER, THE AMPLITUDE IS TURNED ALL THE WAY UP AND THE PATIENT CANNOT FEEL THE STIMULATION. THE PATIENT WAS ADVISED TO TURN THE SCS SYSTEM OFF AS IT IS A POSSIBILITY THAT THE LEAD HAS MIGRATED INTO THE POCKET. FOLLOW UP ON THIS MATTER REVEALED X-RAY IMAGERY CONFIRMED BOTH LEADS HAD MIGRATED. THE IPG SITE PAIN IS RELATED TO LEAD MIGRATION. IT WAS NOTED WHEN THE SCS SYSTEM WAS TURNED OFF THE PAIN RESOLVED. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253671 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL-NEUROMODULATION 3186 4276996

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other