BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2792065 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-11488
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    October 20, 2010
    Report Date
    September 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE LEFT LEAD WAS NOT PROVIDING STIMULATION, AND ONLY THE RIGHT LEAD WAS PROVIDING COVERAGE. IT WAS REPORTED THE IMPEDANCE WERE WITHIN NORMAL RANGE. IT WAS REPORTED THE LEAD AT ISSUE MAY NOT HAVE BEEN UTILIZED SINCE IMPLANT. F/U IDENTIFIED THE PHYSICIAN MAY UNDERTAKEN SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3190279

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788