BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2160755 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-01721
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 (B)(6) RECEIVED AN SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2011. IT WAS REPORTED THAT THE PT COMPLAINED THAT THE IPG SITE IN THE ABDOMINAL REGION WAS PAINFUL. THE PAIN ALLEGEDLY STARTED A MONTH AFTER IMPLANT, AND IT HAD GRADUALLY WORSENED. IT WAS REPORTED THAT BECAUSE OF THE PAINFUL SITE, THE PT WAS UNABLE TO CHARGE THE IPG BATTERY AND TO TOUCH THE SITE WITH THE PROGRAMMER WAND. THEREFORE, THE IPG WAS NO LONGER IN USE SINCE THE BATTERY WAS NOT CHARGED. THE PHYSICIAN EXPLANTED THE IPG ON (B)(6) 2011. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3179697

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention