BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2875186 · Received December 13, 2012

    Report

    Report Number
    1627487-2012-14179
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION. THE PT REPORTED, SHE FELT A PULL AT HER IPG SITE AND THEN SHE EXPERIENCED A CHANGE IN HER STIMULATION COVERAGE. AN SJM REP MET WITH THE PT AND LEAD DIAGNOSTICS SHOWED MULTIPLE INVALID IMPEDANCES. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS HAVE BEEN ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3175272

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788