BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4193313 · Received October 20, 2014

    Report

    Report Number
    1627487-2014-12692
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 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 INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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

    IT WAS REPORTED THE PHYSICIAN PLACED A LEAD FOR A PERMANENT PROCEDURE. THE LEAD WAS TESTED BUT DID NOT PROVIDE STIMULATION. THE PHYSICIAN REPOSITIONED THE LEAD, BUT THE ISSUE WAS NOT RESOLVED. THE LEAD WAS REMOVED. THE PHYSICIAN PLACED A NEW LEAD WHICH RESOLVED THE ISSUE. THE SURGERY WAS EXTENDED BY 20 MINUTES DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667085 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4648342

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other SCS IPG: MODEL 3789| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)