BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 2881027 · Received December 14, 2012

    Report

    Report Number
    1627487-2012-11828
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 25, 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 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 PT HAD PAIN IN THE CHEST AND STOMACH. THE PT WENT TO THE ER, AND THE SCS SYSTEM WAS INTERROGATED. IT WAS REPORTED SOME CONTACTS ON THE LED WERE LOW. IN ADDITION, IT WAS REPORTED THE PT DID NOT HAVE THE STIMULATION ON WHEN THE PAIN HAD STARTED. THE PT WAS ADVISED TO LEAVE THE SCS SYSTEM TURNED OFF AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3594017

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R IMPLANT DATE:| SCS IPG: MODEL 3788