BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2934649 · Received January 4, 2013

    Report

    Report Number
    1627487-2013-02027
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING #: 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 WANTS HER SYSTEM REMOVED. SHE STATED SHE HAD NOT USED HER SYSTEM IN OVER TWO YEARS DUE TO LACK OF PAIN RELIEF. SHE REPORTED SHE HAD NOT CHARGED HER IPG DURING THAT TIME AND ATTEMPTS TO COMMUNICATE WITH THE IPG WERE UNSUCCESSFUL. SURGICAL INTERVENTION WILL LIKELY BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5552 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 174962

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR SCS IPG: MODEL 3186 (2)| IMPLANT DATE: