BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2864330 · Received December 6, 2012

    Report

    Report Number
    1627487-2012-12736
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2012-12737. IT WAS REPORTED THE PATIENT NO LONGER HAS STIMULATION BECAUSE PATIENT'S EXTERNAL DEVICES CANNOT ESTABLISH COMMUNICATION WITH THE IPG. THE PATIENT WAS SENT A NEW CHARGER.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2012-12737. IT WAS REPORTED THE PATIENT NO LONGER HAS STIMULATION BECAUSE PATIENT'S EXTERNAL DEVICES CANNOT ESTABLISH COMMUNICATION WITH THE IPG. THE PATIENT WAS SENT A NEW CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2897071

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)| IMPLANT DATE: