BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3960631 · Received July 21, 2014

    Report

    Report Number
    1627487-2014-24040
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 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 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

    PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT'S SCS LEADS WERE EXPLANTED AND REPLACED DUE TO INEFFECTIVE STIMULATION. IT WAS ALSO REPORTED THE PATIENT'S SCS IPG WAS ELECTIVELY EXPLANTED AND REPLACED WITH A DIFFERENT MODEL. STIMULATION WAS RESTORED WITH THE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426646 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3883578

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192(2)| SCS IPG: MODEL 3788