BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2000723 · Received February 17, 2011

    Report

    Report Number
    1627487-2011-00234
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2008 INCLUDING AN IPG AND PERCUTANEOUS LEAD. IT WAS REPORTED THAT HER IPG WAS ELECTIVELY REMOVED ON (B)(6) 2011. THE DEVICE WAS THE ONLY COMPONENT OF HER SCS SYSTEM THAT REMAINED IMPLANTED. HER LEAD WAS REMOVED ON (B)(6) 2010. SEE MFR. REPORT# 1627487-2010-03332. THE EXPLANTED DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 118834

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention