BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2993986 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-03305
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 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 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

    THE PATIENT RECEIVED 2 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT EXPERIENCES NAUSEA AND A SICK FEELING WHEN INCREASING SYSTEM STIMULATION TO THE DESIRED LEVEL. A SJM REP WAS UNABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING. THE PATIENT WAS ADVISED TO TURN HER SCS SYSTEM OFF AND IS WORKING WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89448 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3558619

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL 3383 (2)| SCS ANCHOR: MODEL 1192 (2)| SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE: