BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2113841 · Received May 17, 2011

    Report

    Report Number
    1627487-2011-01536
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    October 11, 2010
    Report Date
    April 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    IT WAS REPORTED THAT THE PATIENT'S PAIN RELIEF IS NOT AS EFFECTIVE WHEN THE IPG CHARGE LEVEL IS AT 3/4 OF THE POWER LEFT. SHE STATED THAT SHE MUST CHARGE THE IPG WHEN IT IS 1/2 FULL DUE TO THE INEFFECTIVE STIMULATION. THE PATIENT ALLEGED THAT SHE HAS EXPERIENCED THIS ISSUE SINCE THE IPG IMPLANT DATE. FOLLOW UP ON THE PATIENT FOUND THAT SHE HAS BEEN CHARGING MORE FREQUENTLY AND HAS BETTER RELIEF; HOWEVER, SHE STILL HAS A LOSS OF EFFECTIVE STIMULATION AFTER THE IPG CHARGE FALLS BELOW 3/4 FULL. SHE STATED THAT SHE TURNS UP THE AMPLITUDE WHEN THE PAIN RELIEF HAS DECREASED, BUT EVENTUALLY THIS ACTION DOES NOT COMPENSATE. 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 3788 3158086

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention IMPLANTED:| SCS LEAD, MODEL: 3186