BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 6103700 · Received November 15, 2016

    Report

    Report Number
    1627487-2016-05914
    Event Type
    Injury
    Date Received
    November 15, 2016
    Report Date
    June 20, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS EXPERIENCING INTERMITTENT BURNING SENSATION AT THE IPG SITE AND IS REQUESTING AN EXPLANT. IN ADDITION, THE PATIENT REPORTS SHE HAS NOT RECHARGED HER IPG FOR A YEAR (REFERENCE MFR. REPORT: 1627487-2016-05921).SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION IDENTIFIED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2017 WHERE THE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752410 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3761135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 1192(2), SCS ANCHOR