BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 4554308 · Received February 27, 2015

    Report

    Report Number
    1627487-2015-25032
    Event Type
    Injury
    Date Received
    February 27, 2015
    Date of Event
    November 9, 2014
    Report Date
    March 3, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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.

    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.

    Description of Event or Problem · 1

    THE PATIENT (B)(6) IS A PARTICIPANT IN A CLINICAL STUDY (NMD RELIEF REGISTRY). IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE SCS SYSTEM. THE PATIENT WAS IMPLANTED WITH TWO LEADS. CONCOMITANT PRODUCTS IMPLANT DATES ARE UNKNOWN FOR THE FOLLOWING: MODEL: 3383(X2), SCS EXTENSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140157 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other MODEL: 3788, SCS IPG| MODEL: 3383(X2), SCS EXTENSIONS