BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850264 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-01314
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    February 19, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODUALTION
    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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED STIMULATION IS INEFFECTIVE AND IS NO LONGER CONTROLLING THE PT'S PAIN. FOLLOW-UP IDENTIFIED THE RIGHT LEADS APPEARS TO BE FRACTURED AT THE LEAD ANCHOR SITE. REPROGRAMMING WAS UNSUCCESSFUL. THE PT WILL DECIDE THE NEXT COURSE OF ACTION AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290582 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODUALTION 3186 3799210

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192(2)