BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2780359 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-01817
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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: 1627487-2012-01818. IT WAS REPORTED, THE PATIENT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION. HE DID NOT USE HIS SCS SYSTEM FOR SEVERAL YEARS DUE TO MULTIPLE UNRELATED HEALTH ISSUES AND SURGERIES, BUT CONTINUED TO CHARGE HIS IPG. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND LEAD DIAGNOSTIC TESTS SHOWED MULTIPLE INVALID CONTACTS. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS WERE TAKEN AND SHOWED A KINK ON THE LEFT LEAD, AND A SLIGHT WAVE ON THE RIGHT LEAD. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2854857

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)