BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2030877 · Received March 22, 2011

    Report

    Report Number
    1627487-2011-00377
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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

    DEVICE 1 OF 3. REFERENCE MFR REPORT #S 1627487-2011-00378 AND 1627487-2011-00379. THE PT WAS IMPLANTED WITH A THORACIC SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG, SURGICAL LEAD, AND LEAD EXTENSION. IT WAS REPORTED THAT THE DEVICES WERE EXPLANTED DUE TO THE PT'S COMPLAINT OF PAIN AT THE IPG AND LEAD IMPLANT SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 2897065

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention