BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2861069 · Received December 3, 2012

    Report

    Report Number
    1627487-2012-02737
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    April 1, 2006
    Report Date
    April 11, 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 2. REF MFR REPORT: 1627487-2012-02738. THE PT INITIALLY RECEIVED HER SCS SYSTEM FOR BACK AND RIGHT LEG PAIN IN 2004. SHE DEVELOPED PAIN IN HER RIGHT ARM AND WAS IMPLANTED WITH AN ADDITIONAL LEAD. SHE REPORTED SHE ONLY RECEIVED EFFECTIVE STIMULATION FOR A SHORT TIME WITH THE ADDITIONAL LEAD. REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. IT WAS ALSO REPORTED THE PT HAD AN ELECTROMYOGRAM WHICH OBSERVED UNUSUAL READINGS IN HER EXTREMITY AS IF THE SYSTEM WAS ON WHEN THE PT REPORTED THE SYSTEM WAS TURNED OFF. NO FURTHER INFO 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 40671

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SCS EXTENSION: MODEL 3383| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3716