BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4013077 · Received August 11, 2014

    Report

    Report Number
    1627487-2014-23525
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 16, 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 INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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 IS NOT RECEIVING STIMULATION. LEAD DIAGNOSTICS SHOWED HIGH IMPEDANCES ON ALL LEAD CONTACTS. X-RAYS WERE TAKEN, BUT DID NOT REVEAL ANY VISIBLE FRACTURES. THE PATIENT MAY UNDERGO SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475778 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3183 3577043

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788| SCS EXTENSION: MODEL 3383| IMPLANT DATE: