BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3926312 · Received June 17, 2014

    Report

    Report Number
    1627487-2014-25447
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 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 INFO 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT# 1627487-2014-2548. IT WAS REPORTED THE PT'S SCS SYSTEM WAS EXPLANTED DUE TO THE PT NOT LIKING THE "BUZZING" SENSATION EXPERIENCED ALL THE TIME. ADDITIONALLY, IT WAS REPORTED REPROGRAMMING ATTEMPTS DID NOT PROVIDE RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355963 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3928106

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE,| SCS ANCHORS: MODEL 1194X21