BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2133566 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-00825
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AN SCS SYSTEM INCLUDING AN IPG. IT WAS REPORTED THAT THE PT'S IPG WAS CAUSING DISCOMFORT DUE TO THE DEVICE'S LOCATION. SURGICAL INTERVENTION WAS UNDERTAKEN TO RELOCATE THE PT'S IPG POCKET. AT THAT TIME, HER IPG WAS ALSO REPLACED WITH A SMALLER MODEL. NO FURTHER ISSUES WERE REPORTED. THE EXPLANTED DEVICE WILL NOT BE RETURNED TO THE MFR.

    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 3716 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention IMPLANTED:| IMPLANT:| SCS LEADS: MODEL UNK| SCS LEADS: MODEL 3186