BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2921797 · Received January 14, 2013

    Report

    Report Number
    1627487-2013-04066
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATIO
    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: 1627487-2013-04067. IT WAS REPORTED THE PATIENT WAS NOT RECEIVING STIMULATION COVERAGE OF HER PAIN PATTERN. IT WAS REPORTED THE RIGHT LEAD WAS CAUSING HER ARM TO PULSE OR DRAW UP, AND THE LEFT LEAD PROVIDES STIMULATION FROM THE HAND TO BICEP. THE PATIENT WAS IMPLANTED FOR PAIN IN THE NECK AND SHOULDERS. IT WAS REPORTED REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. IN ADDITION, THE PATIENT REPORTED SHE HAD CHEST PAIN UNRELATED TO THE STIMULATION. THE PAIN WAS NOT NEAR AN INCISION SITE. THE PHYSICIAN PLANNED TO EXPLANT THE SCS SYSTEM AT A FUTURE DATE PER THE PATIENT'S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20309 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATIO 3189 3737230

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)