BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3110701 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-01524
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    DEVICE 2 OF 3. REFERENCE MFR REPORT: 1627487-2013-1523, 1525. IT WAS REPORTED THE PT'S ENTIRE SCS SYSTEM WAS REMOVED DUE TO INEFFECTIVE STIMULATION. IT WAS ALSO REPORTED THE PT SUFFERED A FALL SEVERAL MONTHS AGO AND HER IPG SITE BECAME UNCOMFORTABLE. THE PT ALSO NEEDED AN MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209180 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 112932

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL 3341