BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2251230 · Received September 12, 2011

    Report

    Report Number
    1627487-2011-04189
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2011. THE PT REPORTED HER CHARGER ANTENNA WAS GETTING HOT WHILE CHARGING. IN ADDITION, THE PT FELT THE IPG WAS HEATING AS WELL. A NEW CHARGER WAS SENT TO THE PT. FOLLOW UP HAS NOT DETERMINED IF THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTAL IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3263366

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANTED: