BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3950213 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-26441
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    March 20, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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

    IT WAS REPORTED THE PT EXPERIENCED HER STIMULATION CHANGING FROM ONE SPOT TO THE OTHER WITHOUT AN ADJUSTMENT OF THE PROGRAM SETTINGS OR TURNING ON/OFF THE SYSTEM. THE PT NEEDS STIMULATION IN HER LOWER BACK AND LEFT LEG AND HIP, HOWEVER, WHEN THE STIMULATION CHANGED IT IS USUALLY FROM THE KNEE DOWN TO HER FEET. THE PT IS NOT IN A PARTICULAR POSITION WHEN THE CHANGE IN STIMULATION OCCURS BUT IS USUALLY SITTING OR LYING DOWN. THE PT STATED SHE DID SUFFER A FALL A FEW MONTHS AGO. X-RAYS AND CT SCAN WAS TAKEN WHICH CONFIRMED THE LEAD HAD NOT MIGRATED. FOLLOW UP INFO IDENTIFIED THE PT WAS RECEIVING EFFECTIVE STIMULATION WHILE AT THE PHYSICIAN'S OFFICE BUT ONCE SHE RETURNED HOME THE STIMULATION CHANGED WITHOUT ANY INTERVENTION BY THE PT. THE PT IS KNOWLEDGABLE ABOUT THE SCS SYSTEM AND THERE WERE NO IMPEDANCE ISSUES. THE PT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014, WHERE THE LEAD WAS REPOSITIONED TO THE LEFT. THE PT IS NO RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376688 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3219 3780780

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: