BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4092090 · Received September 3, 2014

    Report

    Report Number
    1627487-2014-08243
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 12, 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 INFO 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 SCS IPG STOPPED WORKING ONE DAY AFTER THE PATIENT STOOD UP. NO ERROR MESSAGES ARE INDICATED ON THE PATIENT'S EXTERNAL DEVICES, AND THE IPG STILL HAS COMMUNICATION WITH EXTERNAL DEVICES. AN SJM REP MET WITH THE PATIENT BUT WAS UNABLE TO PROVIDE EFFECTIVE STIMULATION THROUGH REPROGRAMMING AS AUTO-REDUCING WOULD OCCUR. THE PATIENT WILL FOLLOW UP WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535400 OCTRODE SCS LEAD, GZB GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3153204

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other SCS ANCHOR, MODEL 1194| IMPLANT DATE:| SCS IPG, MODEL 3788| IMPLANT DATE: