BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3110901 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-13712
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 9, 2012
    Report Date
    April 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    DEVICE 3 OF 3. REFERENCE MFR. REPORT: 1627487-2013-13710 AND 1627487-2013-13711. THE PT REPORTED SHE IS EXPERIENCING PERSISTENT PAIN AT HER IPG SITE. THE PT STATED NORMAL ACTIVITIES RESULT IN PAIN IN HER BUTTOCKS, AT HER IPG SITE, AND THAT RADIATES DOWN HER LEG TO HER FOOT. THE PT'S IPG IS ALONG HER WAISTLINE WHICH GETS IRRITATED WHEN SHE'S WEARING PANTS. IT WAS NOTED THE PT HAS EXPERIENCED THIS PAIN SINCE BEING IMPLANTED WITH THE SYSTEM. THE PT ALLEGEDLY UNDERWENT A SURGICAL PROCEDURE IN (B)(6) 2012 AND HER IPG WAS RELOCATED DEEPER IN THE POCKET. THE PT STATED SHE CONTINUED TO EXPERIENCE THE PAIN EVEN AFTER THE SURGERY IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202405 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3376712

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention