BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 6119277 · Received November 21, 2016

    Report

    Report Number
    1627487-2016-06010
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    September 9, 2016
    Report Date
    November 2, 2016
    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

    THE PATIENT HAS 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PATIENT STATED HER SCS SYSTEM DID NOT PROVIDE ADEQUATE RELIEF FOR HER PAIN. AS SUCH, THE SJM REPRESENTATIVE MET WITH PATIENT FOR REPROGRAMMING AND ADVISED THE PATIENT TO TRY THE NEW PROGRAMS. HOWEVER, THE PATIENT DECLINED TO USE THE PROGRAMS. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2016 WHERE HER ENTIRE SCS SYSTEM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767116 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3308873

    Patients

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