BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 2091584 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-02505
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THE IPG WAS EXPLANTED AND REPLACED DUE TO EROSION. THE PHYSICIAN INDICATED THE EROSION WAS SUBSEQUENT TO THE PT'S RECENT WEIGHT LOSS. THE PT WAS TREATED WITH ORAL ANTIBIOTICS POST-REVISION. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3058483

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SCS ANCHOR: MODEL 1192| IMPLANTED:| IMPLANTED:| SCS LEAD: MODEL 3186