BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3012225 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-00166
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT NUMBER 1627487-2013-00167. THE PATIENT ((B)(6)) WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS FROM DIFFERENT LOTS FOR RIGHT SIDED HEAD AND NECK PAIN (OFF-LABEL). IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN TO DISCONNECT ONE OF THE TWO EXISTING LEADS AND IMPLANT AN ADDITIONAL LEAD ABOVE THE RIGHT EYE. THIS WAS DONE IN AN ATTEMPT TO PROVIDE EFFECTIVE THERAPY COVERAGE FOR THE PATIENT. THE DISCONNECTED LEAD REMAINS IN-SITU. ADEQUATE STIMULATION WAS CAPTURED FOR THE PATIENT FOLLOWING THE PROCEDURE. ADDITIONAL PROGRAMMING WILL BE CONDUCTED AS NEEDED TO ENSURE OPTIMAL THERAPY RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104363 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3189 3542630

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SCS IPG: MODEL 3788| IMPLANT: