BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2894839 · Received December 20, 2012

    Report

    Report Number
    1627487-2012-02866
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-02865. IT WAS REPORTED THE PT FELT STIMULATION WAS TOO "HEAVY" IN HER LEGS AND SHE EXPERIENCED EXCESS RIB STIMULATION. REPROGRAMMING EFFORTS WERE UNABLE TO PROVIDE SUFFICIENT BACK COVERAGE WITHOUT HEAVY STIMULATION IN THE LEGS AND RIBS. AN X-RAY DETERMINED THE LEADS HAD NOT MIGRATED BUT THEY APPEARED TO BE FAVORING THE RIGHT SIDE. IT WAS REPORTED THE PT WAS REFERRED TO A SURGEON FOR A PADDLE LEAD REVISION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3554356

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)