BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3850288 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-26417
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 25, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 1627487-07262012-002-R. 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 THE PATIENT'S IPG FAILED APPROXIMATELY ONE MONTH AGO (EXACT DATE UNKNOWN). THE IPG WAS UNABLE TO COMMUNICATE WITH THE CHARGER OR PROGRAMMER. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPLACE THE IPG. STIMULATION WAS RESUMED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291463 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2847287

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other IMPLANT:| SCS ANCHOR: MODEL 1194 (2)| IMPLANT:| SCS LEAD: MODEL 3186 (2)