BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2780271 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-12207
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 9, 2012
    Report Date
    September 10, 2012
    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

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND A FIELD CORRECTION. 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 1 OF 4. REFERENCE MFR REPORT# 1627487-2012-12208. REFERENCE MFR REPORT# 1627487-2012-12209. REFERENCE MFR REPORT# 1627487-2012-12210. IT WAS REPORTED THE PT WAS FEELING UNCOMFORTABLE TWINGES THAT BEGIN AT THE IPG POCKET SITE AND RADIATE OUTWARD. THE SJM REP MET WITH THE PT FOR REPROGRAMMING, AND IT WAS REPORTED THE ISSUE WAS RESOLVED. IN ADDITION THE PT HAD FELT WARMTH AT THE IPG SITE IN THE PAST, WHICH WAS UNRELATED TO CHARGING THE IPG. THE PT WAS SCHEDULED FOR A FOLLOW UP APPOINTMENT REGARDING THE ISSUE. ON (B)(6) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3428569

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention