BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2182258 · Received July 12, 2011

    Report

    Report Number
    1627487-2011-00954
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 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 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

    THE PT RECEIVED AN IPG ON (B)(6) 2006. IT WAS REPORTED THAT SHE FEELS STIMULATION AT THE IPG SITE WHEN SHE TURNS HER SCS SYSTEM ON AND OFF. THE PT RECENTLY HAD A LEAD ADDED TO HER SCS SYSTEM, AND THE REPORTED OVERSTIMULATION BEGAN SHORTLY THEREAFTER. THE PT IS WORKING CLOSELY WITH HER PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 47591

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS LEAD: MODEL 3183| IMPLANTED:| IMPLANTED:| SCS LEAD ANCHOR: MODEL 1192