BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 5171604 · Received October 23, 2015

    Report

    Report Number
    1627487-2015-26554
    Event Type
    Injury
    Date Received
    October 23, 2015
    Date of Event
    August 12, 2015
    Report Date
    October 1, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED SITUATIONS WHERE HER STIMULATION WAS REDUCING IN INTENSITY AND THEN RETURNING TO THE SET INTENSITY LEVEL. LEAD DIAGNOSTICS REVEALED NO ANOMALIES. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REMOVE AND REPLACE HER IPG ON (B)(6) 2015 WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701405 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 5020893

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other MODEL 1192, SCS ANCHOR