BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3082337 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-01453
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    September 15, 2012
    Report Date
    November 29, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    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

    FOLLOW-UP REVEALED THE IPG WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL ON (B)(6) 2016. THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT IS UNABLE TO COMMUNICATE WITH OR CHANGE HIS IPG. HE HAS NOT CHARGED HIS IPG FOR OVER 5 MONTHS. SURGICAL INTERVENTION MAY BE PENDING IN THE FUTURE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164159 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3584301

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3286| IMPLANT DATE:| SCS EXTENSION: MODEL 3341| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (3)