BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3979964 · Received July 24, 2014

    Report

    Report Number
    1627487-2014-02518
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 6, 2010
    Report Date
    July 2, 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

    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: 1627487-2014-02519. THE PT RECEIVED TWO MODEL 3166 LEADS FROM LOT # 3075278, AND TWO MODEL 3149 LEADS FROM LOT # 3090623. IT WAS REPORTED THE PT COMPLAINED SHE HAS NOT RECEIVED ANY MIGRAINE RELIEF FROM HER SYSTEM. THE PT STATED HER PERMANENT SYS WORKED FOR APPROXIMATELY ONE MONTH BUT HAS NOT PROVIDED ANY RELIEF SINCE. THE PT STATED HER SYSTEM HAS BEEN REPROGRAMMED MULTIPLE TIMES WITHOUT SUCCESS. IN ADDITION, THE PT REPORTED HER IMPLANT SURGICAL INCISION SITES ARE STILL PAINFUL. ADDITIONAL INFO RECEIVED IDENTIFIED THE PT'S SCS SYSTEM WAS REMOVED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435353 QUATTRODE SCS LEAD GZF ST JUDE MEDICAL - NEUROMODULATION 3166 3075278

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SCS EXTENSION: MODEL 3346 (X2)| SCS IPG: MODEL 3716| IMPLANT DATE:| IMPLANT DATE: