BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3032013 · Received March 26, 2013

    Report

    Report Number
    1627487-2013-12397
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2013-12398. IT WAS REPORTED THE PATIENT'S CHARGING UNIT WAS GETTING HOT WHILE CHARGING. THE PATIENT HAS NOT USED THE CHARGER OR THE PROGRAMMER SINCE DECEMBER. A NEW CHARGER WAS SENT TO THE PATIENT BUT WAS UNABLE TO COMMUNICATE WITH THE IPG. THE SJM REPRESENTATIVE INTERROGATED THE SYSTEM AND WAS UNABLE TO ESTABLISH COMMUNICATION WITH ANY OF THE PATIENT'S CHARGERS, PROGRAMMER, AND EXTRA EXTERNAL DEVICES. THE PATIENT IS CONSIDERING AN EXPLANT OR A REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123707 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2852894

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL 3341| SCS LEAD: MODEL 3186 (2)| SCS LEAD: MODEL 3146| IMPLANT DATE:| IMPLANT DATE: