BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 8103312 · Received November 26, 2018

    Report

    Report Number
    1627487-2018-12323
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    November 14, 2018
    Report Date
    November 26, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN EXPLANT PROCEDURE (REFERENCE MFR. REPORT# 1627487-2018-11603), THE PATIENT'S IPG WAS SURROUNDED BY A MILKY SUBSTANCE. REPORTEDLY, PARTICULAR PARTS OF THE PATIENT'S IPG WAS CALCIFIED. IN TURN, CULTURES WERE PRESUMED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942955 EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 67903

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 3186 (2), SCS LEADS