BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 6015631 · Received October 10, 2016

    Report

    Report Number
    1627487-2016-05257
    Event Type
    Injury
    Date Received
    October 10, 2016
    Report Date
    September 20, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2016-05258. THE PATIENT RECEIVED TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT DOES NOT FEEL THE STIMULATION UNLESS PRESSURE IS APPLIED ON THE IPG. THE PATIENT SUFFERED A FALL AND A LEAD DISCONNECTION IS SUSPECTED. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664912 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3269084

    Patients

    Seq Age Sex Outcome Treatment
    1 Other