BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3931889 · Received June 20, 2014

    Report

    Report Number
    1627487-2014-00360
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    September 26, 2013
    Report Date
    May 26, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2014-00386. THE PATIENT (B)(6) WAS IMPLANTED WITH TWO 8-CHANNEL LEADS FROM THE SAME LOT. IT WAS REPORTED THAT SINCE IMPLANT, THE PATIENT HAD NOT RECEIVED EFFECTIVE STIMULATION COVERAGE. SURGICAL INTERVENTION WAS UNDERTAKEN WITH THE INTENT OF REPOSITIONING THE DEVICES; HOWEVER, FOLLOWING PLACEMENT AND INTRAOPERATIVE TESTING WITH TWO 4-CHANNEL LEADS, THE PHYSICIAN DECIDED TO EXPLANT BOTH OF THE ORIGINAL DEVICES AND IMPLANT A NEW 8-CHANNEL LEAD AT A DIFFERENT VERTEBRAE LEVEL DUE TO THE PATIENT'S HIGH POWER REQUIREMENTS. ADEQUATE THERAPY COVERAGE WAS CAPTURED FOR THE PATIENT FOLLOWING THE PROCEDURE. THE TWO 4-CHANNEL LEADS (FROM THE SAME LOT) INITIALLY INTENDED TO SERVE AS REPLACEMENT DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364072 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4155066

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SCS IPG: MODEL 3788| IMPLANT DATE: