BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 5552371 · Received April 6, 2016

    Report

    Report Number
    1627487-2016-01665
    Event Type
    Injury
    Date Received
    April 6, 2016
    Date of Event
    February 24, 2016
    Report Date
    March 15, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HIS SCS SYSTEM STOPPED WORKING APPROXIMATELY 1.5-2 YEARS POST IMPLANT. FURTHER REVIEW OF THE PATIENT'S RECORDS IDENTIFIED THE PATIENT REPORTED OF HAVING EXPERIENCED INEFFECTIVE STIMULATION AND THE PATIENT DISCONTINUED USING THE SCS SYSTEM IN 2013 (REFERENCE MFR. REPORT: 1627487-2013-18143). SUBSEQUENTLY, SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT AND REPLACE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205504 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3597324

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other