BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4172643 · Received October 13, 2014

    Report

    Report Number
    1627487-2014-20308
    Event Type
    Injury
    Date Received
    October 13, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    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 2 OF 5. REF. MFR. REPORTS # 1627487-2014-20307, 20309, 20310, 20311. IT WAS REPORTED THE PT EXPERIENCED INEFFECTIVE STIMULATION. IN TURN, THE PT STOPPED USING HER SCS SYSTEM AND DID NOT CHARGE THE IPG FOR ABOUT 8 MONTHS. THE SJM REPRESENTATIVE CONFIRMED THE IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, THE SCS SYSTEM WAS EXPLANTED. THE PT RECEIVED TWO OCCIPITAL LEADS (OFF-LABEL) OF MODEL # 3166 AND TWO SUPRA-ORBITAL LEADS (OFF-LABEL) OF MODEL # 3169.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647289 QUATTRODE SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3169 3254416

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other SCS LEADS EXTENSION, MODEL 3346 (2)| IMPLANT DATE: