BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 7143592 · Received December 22, 2017

    Report

    Report Number
    1627487-2017-08651
    Event Type
    Injury
    Date Received
    December 22, 2017
    Report Date
    December 22, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    162487-07262012-002-R; 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. THE 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A SURGERY ON (B)(6) 2017 TO REPLACE THEIR IPG. THE DEVICE WAS INOPERABLE DUE TO RECHARGING ISSUES. THE PATIENT HAS BEEN IMPLANTED WITH A NEW IPG. THERAPY HAS BEEN RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923147 EON MINI IPG, 16-CHANNEL RECHARGEABLE 3788 LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2777973

    Patients

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