BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 2850118 · Received November 27, 2012

    Report

    Report Number
    1627487-2012-11722
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 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 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

    IT WAS REPORTED, THE PT HAD BEEN IN A MOTOR VEHICLE ACCIDENT, AND THE STIMULATION HAD CHANGED. THE PT HAD BEEN REPROGRAMMED AND REGAINED COVERAGE, HOWEVER, THE PT HAD REQUESTED MORE STIMULATION COVERAGE FOR HER FOOT. THE PHYSICIAN PERFORMED A TRIAL PROCEDURE ON (B)(6) 2012 TO DETERMINE IF COVERAGE COULD BE OBTAINED. IT WAS REPORTED THE TRIAL WAS SUCCESSFUL, AND A NEW LEAD WOULD BE PLACED WITH THE EXISTING SCS SYSTEM AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3219 3463281

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: