BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110867 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-04578
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT HAD DIFFICULTY COMMUNICATING WITH THE CHARGING SYSTEM. IT WAS REPORTED THE IPG MAY HAVE BEEN ANGLED IN THE POCKET SITE. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. F/U IDENTIFIED THE REPLACEMENT DEVICE DID NOT RESOLVE THE ISSUE. THE PHYSICIAN SURGICALLY REPOSITIONED THE IPG ON (B)(6) 2013, TO RESOLVE THE ISSUE. F/U IDENTIFIED THE ISSUE WAS RESOLVED AND THE PT WAS ABLE TO RECHARGE THE IPG SUCCESSFULLY POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204938 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3613088

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: