BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2190932 · Received July 19, 2011

    Report

    Report Number
    1627487-2011-03301
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PT RECEIVED AN SCS SYS ON (B)(6) 2011. IT WAS REPORTED THAT THE PT FEELS A 'THRUSTING' SENSATION WHEN HER IPG BATTERY IS GETTING LOW. A POSSIBLE REPLACEMENT IS BEING DISCUSSED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3145892

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention IMPLANTED:| IMPLANTED:| IMPLANTED:| SCS EXTENSION: MODEL 3346 (2)| SCS LEAD: MODEL 3166 (2)| SCS LEAD: MODEL 3149 (2)