BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2190772 · Received July 26, 2011

    Report

    Report Number
    1627487-2011-03363
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-03170. THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT IS CURRENTLY WITHOUT STIMULATION. THE PROGRAMMER IS SHOWING SEVERAL ERRORS AND THE AMPLITUDE OF PROGRAM 1 STOPPED AT PERCEPTION LEVEL. THE PT HAS A POSSIBLE INFECTION AROUND THE IPG. THE PT IS BEING TREATED WITH IV ANTIBIOTICS. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3218898

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R