BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2881351 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-02806
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 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 INFO 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

    DEVICE 1 OF 3. REF MFR REPORT: 1627487-2012-02807 AND 1627487-2012-02808.. IT WAS REPORTED THE PT HAD EFFECTIVE STIMULATION COVERAGE BUT DID NOT RECEIVED ADEQUATE PAIN RELIEF FROM HIS SCS SYSTEM. REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. IT WAS REPORTED THE PT UNDERWENT A TRIAL FOR A PAIN PUMP AND THERE ARE CURRENTLY NO PLANS TO REMOVE HIS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2886917

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention