BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2881340 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-02821
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 20, 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 4. REFERENCE MFR REPORTS: 1627487-2012-02820, 16267487-2012-02822, 1627487-2012-02823. THE PATIENT RECEIVED TWO SCS SYSTEMS AND HAS SIX PERCUTANEOUS LEADS (FROM FOUR SEPARATE LOTS). IT WAS REPORTED THE PATIENT THORACIC SCS SYSTEM WAS NOT PROVIDING HER ADEQUATE STIMULATION COVERAGE. SHE STATED SHE WANTED STIMULATION IN HER THIGHS AND HAD QUIT USING THIS SYSTEM DUE TO THE ISSUE. REPROGRAMMING EFFORTS WERE UNABLE TO PROVIDE COVERAGE TO THE THIGH AREA BUT THE PATIENT REPORTED GOOD PAIN RELIEF IN OTHER AREAS. IT WAS REPORTED THE PATIENT DID NOT WISH TO DO ANYTHING FURTHER AT THIS TIME. AS THE AFFECTED LEADS ARE UNKNOWN, ALL OF THE PATIENT'S LEADS ARE BEING REPORTED (DEVICE 1, 2, 3 AND 4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3290702

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCS IPG: MODEL 3788 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (6)| IMPLANT DATE:| SCS EXTENSION: MODEL 3341 (2)| IMPLANT DATE: