BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2864491 · Received December 6, 2012

    Report

    Report Number
    1627487-2012-11777
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 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 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 DID NOT HAVE STIMULATION, AND WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE ISSUE. IT WAS REPORTED THE PATIENT HAD NOT CHARGED THE IPG FOR SOME TIME DUE TO A RECENT NATURAL DISASTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3486913

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3219