BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3926120 · Received June 13, 2014

    Report

    Report Number
    1627487-2014-02418
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    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 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: REF MFR REPORT: 1627487-2014-02419. THE PT RECEIVED TWO SCS LEADS FOR THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS NOT RECEIVING ANY STIMULATION THERAPY FROM HIS SCS SYSTEM. THE PT STATED HIS STIMULATION HAD BEEN INTERMITTENT. A DIAGNOSTICS OF THE PT'S SYSTEM REVEALED ALL THE CONTACTS ARE INVALID FOR BOTH LEADS. ADDITIONAL INFO RECEIVED ON (B)(6) 2014 IDENTIFIED THE PT'S SCS LEAD WERE EXPLANTED AND REPLACED. IT WAS OBSERVED THE LEADS APPEARED FRACTURED WITH FLUID INSIDE THE CASING. IN ADDITION, IT WAS UNCERTAIN IF ANY FLUID INTRUDED IN THE PT'S IPG, THEREFORE, THE PHYSICIAN DECIDED TO REPLACE THE PT'S IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349120 QUATTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3146 4198758

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR