BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3231490 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-12923
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    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

    IT WAS REPORTED THE PHYSICIAN WAS PLACING A NEW LEAD ON (B)(6) 2014 TO PROVIDE ADDED COVERAGE. THE PATIENT FELT A SHARP ELECTRIC PAIN IN THE LOWER RIGHT QUADRANT DURING THE LEAD PLACEMENT. THE PHYSICIAN REMOVED THE LEAD AND ABANDONED THE PROCEDURE. FOLLOW-UP REVEALED THE PATIENT'S PAIN HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323690 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3853490

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| SCS IPG: MODEL 3788