BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 8146518 · Received December 10, 2018

    Report

    Report Number
    1627487-2018-12663
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    November 14, 2018
    Report Date
    January 8, 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
    VA, 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

    UPDATED EVENT DESCRIPTION TO INCLUDE INFORMATION: PATIENT FAILED TO CHARGE. ADDED PMA CODE P010032. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2018 WHERE THEIR ORIGINAL IPG WAS REPLACED DUE TO THE DEVICE BEING INOPERABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IPG WAS INOPERABLE DUE TO THE PATIENT NOT CHARGING THE IPG SINCE (B)(6) 2018. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2018 WHERE THEIR ORIGINAL IPG WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987435 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3444817

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR 3788ANS