BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2762476 · Received September 24, 2012

    Report

    Report Number
    1627487-2012-02377
    Event Type
    Injury
    Date Received
    September 24, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LQW
    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 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

    THE PT REC'D TWO SUPRAORBITAL LEADS (FROM THE SAME LOT) AND TWO OCCIPITAL LEADS AS PART OF HER NEUROSTIMULATOR SYSTEM (OFF-LABEL). IT WAS REPORTED THE PT WAS UNHAPPY WITH HER STIMULATION COVERAGE AND AN X-RAY SHOWED POSSIBLE LEAD MIGRATION FOR HER RIGHT SUPRAORBITAL LEAD. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LQW ST. JUDE MEDICAL - NEUROMODULATION 3166 3714576

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3149 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3166| SCS IPG: MODEL 3716| IMPLANT DATE:| SCS EXTENSION: MODEL 3346 (2)