BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3182171 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-01696
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION. THE PATIENT UNDERWENT SURGERY WHERE HER IPG ONLY WAS REMOVED. THERE IS NO KNOWN ISSUE WITH THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272297 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL -NEUROMODULATION 3219 2891020

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788