BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3701420 · Received February 20, 2014

    Report

    Report Number
    1627487-2014-01127
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 27, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL NUMBER.: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REFERENCE MFR REPORT # 1627487-2014-01125. REFERENCE MFR REPORT # 1627487-2014-011126. IT WAS REPORTED ONE OF THE LEADS BECAME DISCONNECTED RESULTING IN PARTIAL STIMULATION COVERAGE. SURGICAL INTERVENTION MAY BE CONSIDERED AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107849 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 R173704

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other