BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 8784494 · Received July 12, 2019

    Report

    Report Number
    3006705815-2019-02612
    Event Type
    Injury
    Date Received
    July 12, 2019
    Report Date
    August 6, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05414734402651
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH THE 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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED PAIN AT THE IPG SITE FOR THE THORACIC SYSTEM FOR SEVERAL MONTHS. X-RAYS DID NOT REVEAL ANY MIGRATION .TO ADDRESS THIS ISSUE PATIENT MAY BE AWAITING SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT HAD A POCKET REVISED ON (B)(6) 2019. EFFECTIVE THERAPY WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578524 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3788 4585521 05414734402651

    Patients

    Seq Age Sex Outcome Treatment
    1 Other