BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3223177 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-15949
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 19, 2013
    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

    THE PATIENT WAS IMPLANTED WITH 2 LEADS (FROM THE SAME LOT) AS PART OF HIS SCS SYSTEM. IT WAS REPORTED, THE PATIENT IS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT STATED, HE EXPERIENCED A SUDDEN CHANGE IN STIMULATION. THE PATIENT DENIES ANY FALLS. THE SJM REPRESENTATIVE MET WITH THE PATIENT FOR REPROGRAMMING WHICH WAS NOT ABLE TO PROVIDE STIMULATION TO THE PROPER AREAS. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314603 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3986501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: