BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4142882 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-08302
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    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 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 PT HAS TWO MODEL 3186 LEADS FROM THE SAME LOT. IT WAS REPORTED THE PT WAS EXPERIENCING A HEADACHE. NO ANOMALIES WERE NOTED DURING THE PT'S IMPLANT PROCEDURE ON (B)(6) 2014. THE PT WAS ADVISED TO REST AND HYDRATE. ADDITIONAL INFO RECEIVED IDENTIFIED THE PT'S HEADACHE HAS REPORTEDLY RESOLVED, AND HE CONTINUE TO RECEIVE EFFECTIVE STIMULATION FROM HIS SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591063 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4693424

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (X2)| SCS IPG: MODEL 3789| IMPLANT DATE: