BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3891877 · Received June 10, 2014

    Report

    Report Number
    1627487-2014-23391
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ST. JUDE MED - 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 MED 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 MED HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT# 1627487-2014-23392. IT WAS REPORTED DUE TO LEAD MIGRATION, THE PT UNDERWENT SURGICAL INTERVENTION WHERE HER LEADS WERE REPLACED WITH NEW ONES. IN ADDITION, THE PHYSICIAN ELECTIVELY REMOVED AND REPLACED THE PT'S IPG. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341013 OCTRODE SCS LEAD GZB ST. JUDE MED - NEUROMODULATION 3186 63642

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other IMPLANT DATE:| SCS IPG, MODEL 3716