BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 4974028 · Received August 5, 2015

    Report

    Report Number
    1627487-2015-26368
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 18, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT EMERGENT SURGICAL INTERVENTION TO REMOVE AND REPLACE THE LEAD AS THE LEAD BODY WAS EXPOSED THROUGH THE SKIN. THE PATIENT IS RECEIVING EFFECTIVE STIMULATION AND HAS SUFFERED NO ADVERSE EVENTS FROM THE LEAD EROSION. IN ADDITION THE IPG WAS ELECTIVELY REPLACED TO TAKE ADVANTAGE OF NEW TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512381 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4455274

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other MODEL 1192 (2), SCS ANCHOR| MODEL 3788, SCS IPG