BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3202333 · Received June 27, 2013

    Report

    Report Number
    1627487-2013-13443
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    December 1, 2012
    Report Date
    March 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-13442. THE PT HAS TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT EXPERIENCED PAIN AT HER IPG AND LEAD ANCHOR SITE. NO MORE INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293196 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 68280

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention