BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4091804 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-25585
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    July 11, 2012
    Report Date
    August 4, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    IT WAS REPORTED THE PT ((B)(6)) UNDERWENT SURGICAL INTERVENTION TO EXPLANT AND REPLACE (WITH A DIFFERENT MODEL) THE LEADS DUE TO LEAD MIGRATION. EFFECTIVE THERAPY WAS RESTORED POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526119 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other