BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3931666 · Received June 23, 2014

    Report

    Report Number
    1627487-2014-25464
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 2, 2014
    Report Date
    June 2, 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. REFERENCE MFR. REPORT#: 1627487-2014-25465. THE PATIENT HAS A PNS AND SCS SYSTEM. THE EVENT IS RELATED TO THE PNS SYSTEM. IT WAS REPORTED, THE PATIENT IS NOT RECEIVING STIMULATION. DIAGNOSTICS REVEALED NO ANOMALIES. REPROGRAMMING WAS UNSUCCESSFUL. THE PHYSICIAN BELIEVES THE PATIENT HAS SIGNIFICANT SCARRING AROUND THE LEADS WHICH IS CAUSING A LOSS OF THERAPY. THE PATIENT WAS REFERRED TO A NEUROSURGEON AND WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367057 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3234936

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other IMPLANT DATE:| SCS ANCHORS: MODEL 1192 (X2)| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS EXTENSION: MODEL 2343