BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850299 · Received May 30, 2014

    Report

    Report Number
    1627487-2014-26466
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    March 11, 2014
    Report Date
    May 9, 2014
    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

    DEVICE 1 OF 2. REF MFR. REPORT# 1627487-2014-26467. IT WAS REPORTED THE PT WAS NOT RECEIVING STIMULATION TO HER BACK. THE PT REPORTS SHE HAS NOT HAD EFFECTIVE STIMULATION IN HER LOW BACK SINCE SHE WAS IMPLANTED, HOWEVER SHE HAD EFFECTIVE STIMULATION IN HER LOW BACK DURING THE TRIAL. THE PT DENIES FALLING OR TRAUMA FOLLOWING. PHYSICIAN FOLLOW UP APPOINTMENT IS PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319899 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4081405

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE:| SCS IPG, MODEL 3788| IMPLANT DATE: