BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2772017 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-02405
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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 RECEIVED TWO PNS LEADS AS PART OF HER SYSTEM (OFF-LABEL). IT WAS REPORTED THAT ONE OF THE PATIENT'S PNS LEADS IS CAUSING HER PAIN WHEN STIMULATION IS TURNED ON. IT WAS REPORTED SURGICAL INTERVENTION WILL TAKE PLACE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3473759

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788| SCS LEAD: MODEL 3186| IMPLANT: