BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 9013799 · Received September 12, 2019

    Report

    Report Number
    1627487-2019-10374
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    July 31, 2019
    Report Date
    September 12, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO INCREASE AMPLITUDE TO A STRENGTH THAT COVERED TARGETED PAIN AREAS AND ALSO EXPERIENCED CHANGES IN STIMULATION WHEN IN DIFFERENT POSITIONS. FIELD REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMED THE DEVICE USING BURSTDR WHICH YIELDED SUCCESSFUL RESULTS. AS A RESULT, THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2019 AFTER A SUCCESSFUL BTE. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY. POSITIONAL STIMULATION HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796694 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3479554

    Patients

    Seq Age Sex Outcome Treatment
    1 Other