BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IPG

    MDR report key: 3032303 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-13445
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 5, 2013
    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 INFORMATION 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 1 OF 3. REFERENCE MFR. REPORT: 1627487-2013-13446 & 1627487-2013-13447. IT WAS REPORTED WHEN THE PT'S STIMULATION WAS TURNED ON, SHE EXPERIENCED WHAT SHE DESCRIBED AS A "SHOCKING SENSATION" THROUGH HER BODY WHEN SHE MOVED A CERTAIN WAY. THE PT WAS IMPLANTED WITH TWO COMPETITORS LEADS, DIAGNOSTIC TESTING DISCOVERED 5 OUT OF THE 8 ELECTRODES SHOWED INVALID IMPEDANCES. X-RAYS WERE ORDERED TO SEE IF THERE WERE ANY LEAD FRACTURES. IT WAS NOTED THE PT STILL HAD STIMULATION COVERAGE USING 3 WORKING ELECTRODES, HOWEVER, SHE COULD NOT TOLERATE THE SHOCKING SENSATION. FOLLOW-UP INFORMATION IDENTIFIED THE PT UNDERWENT A SURGICAL PROCEDURE AND THE LEADS AND ADAPTERS WERE EXPLANTED. THE IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG. THE PT'S PHYSICIAN OPTED TO DO A LAMINECTOMY AT T9-10 AND PLACED A SJM LEAD AT T9. INTEROPERATIVE TESTING CONFIRMED THE PT WAS RECEIVING EFFECTIVE STIMULATION COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130107 EON IPG SCS LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 46268A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention