BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 8153468 · Received December 11, 2018

    Report

    Report Number
    1627487-2018-12720
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 20, 2018
    Report Date
    January 8, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05414734402583
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    P010032.

    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 BECOMING INOPERABLE AFTER THE PATIENT STOPPED CHARGING IT. REPORTEDLY, EFFECTIVE THERAPY WAS OBTAINED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989946 EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3752928 05414734402583

    Patients

    Seq Age Sex Outcome Treatment
    1 Other