BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2881338 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-02827
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-02826. IT WAS REPORTED THE PATIENT WAS NO LONGER GETTING EFFECTIVE STIMULATION COVERAGE. THE PATIENT ALLEGEDLY WAS ON VACATION AND WENT TO THE EMERGENCY ROOM ABOUT THE ISSUE. REPROGRAMMING EFFORTS PROVIDED SOME STIMULATION COVERAGE, BUT STIMULATION WAS EITHER NOT ENOUGH OR PROVIDED OVER STIMULATION. X-RAYS WERE TAKEN AND THE PHYSICIAN DID NOT FEEL THE LEADS HAD MOVED. IT WAS REPORTED THE PATIENT WILL BE REPROGRAMMED AGAIN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3543287

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788