BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2010780 · Received March 2, 2011

    Report

    Report Number
    1627487-2011-01192
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    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) 2010. IT WAS REPORTED THAT THE IPG WAS CAUSING DISCOMFORT TO THE PATIENT. THE PHYSICIAN REVISED THE IPG SITE FROM THE SHOULDER TO THE BUTTOCK ON (B)(6) 2011. THE PHYSICIAN ALLEGEDLY ADDED TWO 60 CM EXTENSIONS DURING THE PROCEDURE, AND INTRAOPERATIVE TESTING SHOWED NORMAL IMPEDANCE READINGS. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED. AS NO PRODUCT WAS EXPLANTED, THERE WILL BE NO PRODUCT RETURNING TO THE MANUFACTURER FOR ANALYSIS.

    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 DIVISION 3788 3126728

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention