BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4201977 · Received October 17, 2014

    Report

    Report Number
    1627487-2014-25646
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    July 15, 2014
    Report Date
    February 20, 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
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    DEVICE #1 OF 2 - REFERENCE MFR. REPORT: 1627487-2014-25647. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY ((B)(4)). IT WAS REPORTED THE PATIENT ((B)(6)) IS EXPERIENCING PAINFUL STIMULATION. REPROGRAMMING ATTEMPTS DID NOT PROVIDE RESOLUTION. ADDITIONALLY, IT WAS REPORTED THE PATIENT HAD MILD EDEMA AT THE IMPLANT WHICH LATER RESOLVED. IN TURN, THE PATIENT HAD DECLINED SURGICAL INTERVENTION AT THIS TIME TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663345 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3183 4060490

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other SCS IPG: MODEL 3788| SCS EXTENSIONS: MODEL 3383 (X2)| IMPLANT DATE:| IMPLANT DATE: