BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3954933 · Received July 16, 2014

    Report

    Report Number
    1627487-2014-01463
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014. THE INITIAL LEAD CAUSED UNCOMFORTABLE EYE TWITCHING WITH STIMULATION AND AS A RESULT A NEW LEAD WAS ADDED INFERIOR TO THE ORIGINAL LOCATION. THE PHYSICIAN ELECTIVELY REPLACED THE IPG DURING THIS TIME. EFFECTIVE COVERAGE WAS ACHIEVED POSTOPERATIVELY. THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416317 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3149 3880613

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS EXTENSION, MODEL 3383| IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL 3788