BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3012431 · Received March 15, 2013

    Report

    Report Number
    1627487-2013-05366
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 21, 2013
    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 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

    THE PATIENT HAS TWO LEADS (FOR OFF-LABEL USE). IT WAS REPORTED THE LEADS ARE NO LONGER PROVIDING ADEQUATE COVERAGE. IT WAS ALSO REPORTED THE PATIENT EXPERIENCES INTOLERABLE PAIN WHEN STIMULATION IS ON. AN SJM REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT THE ISSUE TO NO AVAIL. AN IMPEDANCE CHECK REVEALED NO ANOMALIES. THE PATIENT WILL MEET WITH HER DOCTOR TO DISCUSS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110280 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3224614

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SCS EXTENSION: MODEL 3343| IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3219| SCS ANCHORS: MODEL 1192 (X2)| IMPLANT:| IMPLANT:| SCS IPG: MODEL 3788