BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 5641522 · Received May 9, 2016

    Report

    Report Number
    1627487-2016-02370
    Event Type
    Injury
    Date Received
    May 9, 2016
    Date of Event
    December 25, 2015
    Report Date
    July 15, 2016
    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
    OTHER

    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.

    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.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION IDENTIFIED THE PATIENT'S SCS IPG WAS REPLACED WITH A DIFFERENT MODEL. IN ADDITION, THE PATIENT REPORTED SHE HAS NOT EXPERIENCED THE "ZAPPING" SENSATION WITH THE NEW IPG.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COMPLAINED SHE HAS BEEN EXPERIENCING OVERSTIMULATION ("ZAPPING") EVERY TIME SHE WALKS THROUGH A SECURITY SCANNER AT VARIOUS SHOPPING CENTERS. THE PATIENT STATED THIS OCCURS WITH THE STIMULATOR TURNED OFF. THE PATIENT STATED THE "ZAPPING" IS PAINFUL. A SJM REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMED THE PATIENT'S SCS SYSTEM, HOWEVER THE ISSUE HAS PERSISTED. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295383 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 4387104

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other