BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 2210411 · Received August 9, 2011

    Report

    Report Number
    1627487-2011-08032
    Event Type
    Injury
    Date Received
    August 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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

    DEVICE 6 OF 6. REFERENCE MFR REPORTS: 1627487-2011-08026, 08027, 08028, 08029, 08030. IT WAS REPORTED BY THE PT THAT THE SCS THERAPY WAS NO LONGER OF BENEFIT IN TREATING THE PT'S PAIN. THE DEVICE HAD BEEN TURNED OFF FOR THREE MONTHS AND THEN THE ENTIRE SCS SYSTEM WAS EXPLANTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3126725

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention