BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2884796 · Received December 3, 2012

    Report

    Report Number
    1627487-2012-02746
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT FELT A TINGLING SENSATION AT THE IPG SITE AFTER HE HAD TURNED OFF HIS IPG FOR TWO DAYS. DIAGNOSTIC TESTING REVEALED NORMAL IMPEDANCE READINGS ON ALL LEAD CONTACTS. IT WAS REPORTED AN X-RAY OF THE PT'S SYSTEM WILL POSSIBLY BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3333247

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SCS LEAD: MODEL 3189| SCS ANCHOR: MODEL 1192| IMPLANTED:| IMPLANTED: