BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 6168317 · Received December 12, 2016

    Report

    Report Number
    1627487-2016-06391
    Event Type
    Injury
    Date Received
    December 12, 2016
    Report Date
    November 18, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DID NOT CHARGE THE IPG AS RECOMMENDED AND THE IPG BECAME INOPERABLE. AS A RESULT, THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2016. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819020 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3491213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL: 3189 (X2), SCS LEADS