BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1940397 · Received December 20, 2010

    Report

    Report Number
    1627487-2010-03844
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 HIS SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT FELT PAIN AT HIS IPG SITE WHILE CHARGING AND DURING STIMULATION. HE REPORTED FEELING A WARM, SOMETIMES PAINFUL, SENSATION TO THE IPG SITE EVEN WHEN STIMULATION IS OFF. THE PATIENT STATED HE FELT A JOLT WHEN STIMULATION IS INITIALLY TURNED ON. A REPLACEMENT CHARGER WAS SENT TO THE PATIENT, AND THE PATIENT WAS SCHEDULED TO MEET WITH A SJM REPRESENTATIVE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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 2929926

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention