BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3052255 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-00205
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    December 20, 2012
    Report Date
    March 13, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    IT WAS REPORTED THE PATIENT (B)(6) IS WITHOUT STIMULATION. A DIAGNOSTIC TEST REVEALED IMPEDANCE ISSUES FOR SEVERAL LEAD CONTACTS. THE PATIENT REPORTEDLY HAS A SIGNIFICANT AMOUNT OF SCAR TISSUE IN THE EPIDURAL SPACE. EFFORTS TO RECAPTURE EFFECTIVE THERAPY THROUGH REPROGRAMMING HAVE PROVEN UNSUCCESSFUL. THERE ARE NO IMMEDIATE PLANS FOR INVASIVE INTERVENTION AS THE PATIENT IS CURRENTLY TRYING ALTERNATIVE THERAPY OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139541 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3636686

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788