BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 8809324 · Received July 19, 2019

    Report

    Report Number
    1627487-2019-08246
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    January 2, 2019
    Report Date
    July 25, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA/510(K) # SHOULD BE P010032 ON THE INITIAL REPORT, WHICH HAS BEEN CORRECTED IN THIS 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. THE DIRECTIONS FOR USE STATES THAT THE IMPLANT MUST BE CHARGED EVERY 30 DAYS TO AVOID BATTERY DEPLETION. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT IS RELATED TO USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE. IT WAS NOTED THAT THE PATIENT STOPPED CHARGING BECAUSE THEY LOST THEIR REMOTE AND MOVED STATES. AS A RESULT, THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2019. ADEQUATE THERAPY WAS ESTABLISHED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601223 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3800688

    Patients

    Seq Age Sex Outcome Treatment
    1 Other