BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4223272 · Received October 29, 2014

    Report

    Report Number
    1627487-2014-05743
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIV, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED. UDI(DI): (B)(4).

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT# : 1627487-2014-05744. THE PATIENT HAS AN SCS SYSTEM FOR OFF-LABEL USE. IT WAS REPORTED ONE OF THE PATIENT'S 3166 LEADS (LOCATED IN THE SUPRA-ORBITAL AREA) HAD ERODED THROUGH HER SKIN. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014. DURING THE PROCEDURE, THE DOCTOR BURIED THE LEAD DEEPER AND CLOSED THE WOUND. BOTH 3166 LEADS ARE BEING REPORTED BECAUSE IT IS UNK WHICH LEAD ERODED THROUGH THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691228 QUATTRODE SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3166 4120154

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL: 3788| IMPLANT DATE:| SCS ANCHORS, MODEL: 1192(X4)| IMPLANT DATE:| SCS EXTENSIONS, MODEL: 3346(X2)| SCS LEADS, MODEL: 3169(X2)