BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3931417 · Received June 26, 2014

    Report

    Report Number
    1627487-2014-05460
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    December 1, 2010
    Report Date
    June 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 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

    THE PT HAS TWO LEADS FROM THE SAME LOT (FOR OFF-LABEL USE). IT WAS REPORTED THE PT STOPPED USING HER SCS SYS DUE TO INEFFECTIVE/POSITIONAL STIMULATION. AS A RESULT, T HE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014. DURING THE PROCEDURE, THE DOCTOR CHOSE TO CLIP THE LEADS AT A LOCATION NEAR THE IPG AND WERE LEFT IN PLACE. THE DOCTOR CHOSE TO DO SO AS A PRECAUTION TO NOT RISK AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373133 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3181 3054808

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other SCS IPG, MODEL: 3788| SCS ANCHOR, MODEL: 1192 (X2)| IMPLANT DATE:| IMPLANT DATE: