BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4151792 · Received October 6, 2014

    Report

    Report Number
    1627487-2014-12658
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 9, 2014
    Report Date
    June 23, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT AND REPLACE THE PATIENT'S IPG.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S IPG IS DISPLAYING A COMMUNICATION ERROR. THE EXTERNAL DEVICES SUDDENLY ARE UNABLE TO COMMUNICATE WITH THE IPG. AN SJM REP CONFIRMED THE COMMUNICATION ISSUE. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622511 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2867468

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other IMPLANT DATE:| SCS EXTENSION, MODLE 3383 AND 3386 (2),