BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 8663355 · Received June 3, 2019

    Report

    Report Number
    1627487-2019-06463
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 16, 2019
    Report Date
    September 27, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED. ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT AND EVENT INFORMATION. FURTHER INFORMATION WAS NOT PROVIDED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION FROM THEIR GENERATOR. AS A RESULT, SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2019 WHEREIN THE SCS IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY HAS BEEN RESTORED, RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458272 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3800688

    Patients

    Seq Age Sex Outcome Treatment
    1 Other