BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3012254 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-00151
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 17, 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
    AS
    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 1 OF 3. REFERENCE MFR REPORT NUMBERS: 1627487-2013-00152 AND 1627487-2013-00153. THE PT (AUSTRALIA) WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS FROM DIFFERENT LOTS. IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN TO DISCONNECT ONE OF THE TWO EXISTING 8-CHANNEL LEADS TO IMPLANT TWO 4-CHANNEL LEADS. THIS WAS BEING DONE IN AN ATTEMPT TO CAPTURE THE PT'S LOWER BACK PAIN. UPON OPENING THE POCKET, IT WAS FOUND THAT THE LEAD IN QUESTION HAD BECOME DISCONNECTED FROM THE IPG HEADER. THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF THE TWO NEW LEADS. THE DISCONNECTED LEAD REMAINS IN-SITU. EFFECTIVE STIMULATION WAS CAPTURED FOR THE PT FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104741 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 2825398

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention