BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3931664 · Received June 23, 2014

    Report

    Report Number
    1627487-2014-00364
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 27, 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 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 2 OF 4. REFERENCE MFR REPORT #S: 1627487-2014-00363, 1627487-2014-00365 AND 1627487-2014-00366. THE PATIENT'S (B)(6) PERIPHERAL NERVE STIMULATION SYSTEM FOR LOWER BACK PAIN (OFF-LABEL) CONSISTS OF FOUR PERCUTANEOUS LEADS FROM TWO DIFFERENT LOTS, TWO EXTENSIONS AND AN IPG. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION COVERAGE. IN ADDITION, IT WAS REPORTED THE PATIENT EXPERIENCES A STABBING PAIN REGARDLESS OF THE STIMULATION'S USE. THE DISCOMFORT IS REPORTEDLY WORSE WHEN THE PATIENT IS WALKING. A DIAGNOSTIC TEST FOUND A LOW IMPEDANCE READING FOR ONE LEAD CONTACT. THE PATIENT RECENTLY HAD HIS NERVE ENDINGS BURNED WHICH IS SAID TO HAVE HELPED THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367008 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3153 4021234

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other