BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2800852 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-02524
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 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 RECEIVED A SYSTEM FOR OCCIPITAL NERVE STIMULATION (OFF-LABEL) WHICH INCLUDED TWO PERCUTANEOUS LEADS FROM THE SAME LOT. IT WAS REPORTED THE PT'S STIMULATION COVERAGE HAD CHANGED AND HER HEADACHES WERE BECOMING MORE FREQUENT. DIAGNOSTIC TESTING REVEALED HIGH AND INVALID IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. THE PT STATED SHE HAD UNDERGONE SEVERAL LEAD REVISION PROCEDURES IN THE PAST. IT WAS REPORTED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3156 56028

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention SCS IPG: MODEL: 3716| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL: 3346