BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4202575 · Received October 22, 2014

    Report

    Report Number
    1627487-2014-01668
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 26, 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 RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT EXPERIENCED OVERSTIMULATION WITH STIMULATION TURNED ON. DIAGNOSTIC TESTING REVEALED ALL IMPEDANCES WITHIN NORMAL RANGE. REPORTEDLY, X-RAYS IDENTIFIED THE LEADS HAVE MIGRATED. FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN, EXPLANTING AND REPLACING THE LEADS. EFFECTIVE COVERAGE WAS ACHIEVED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673670 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4358131

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: