BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3940486 · Received June 18, 2014

    Report

    Report Number
    1627487-2014-02435
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 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 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 2. REFERENCE MFR REPORT: 1627487-2014-02434. THE PATIENT RECEIVED TWO MODEL 3146 SCS LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION THERAPY FROM HER SCS SYSTEM. THE PATIENT STATED HER STIMULATION DOES NOT COVER ALL OF HER PAIN AREAS, AND IS ONLY PARTIALLY EFFECTIVE. THE PATIENT IS PENDING A CONSULTATION WITH HER PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357597 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3146 3719697

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other IMPLANT DATE:| SCS EXTENSION: MODEL 3341| SCS ANCHOR: MODEL 1194| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3383 (X2)| SCS IPG: MODEL 3688| IMPLANT DATE: