BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 3820883 · Received May 13, 2014

    Report

    Report Number
    1627487-2014-12352
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODLUATION
    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 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2014-12351. IT WAS REPORTED THE PATIENT EXPERIENCES A PAINFUL BURNING SENSATION AT THE IPG WHEN THE STIMULATION IS ON. THE PAIN DIMINISHES SOME WHEN THE STIMULATION IS TURNED OFF, BUT THE PAIN IS STILL PRESENT. THE PATIENT ALSO EXPERIENCES A SHOOTING PAIN AT THE IPG SITE THAT RADIATES UP HER BACK. DIAGNOSTIC TESTING REVEALED MANY INVALID CONTACTS AND X-RAYS SHOWED NO ANOMALIES. A PHYSICAL EXAMINATION OF THE IPG AND LEAD CONNECTIONS IS PENDING. SURGICAL INTERVENTION IS UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287506 LAMITRODE TRIPOLE 16C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODLUATION 3219 2796137

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other IMPLANT DATE:| SCS EXTENSIONS: MODEL 3383 (2)