BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16 - CHANNEL RECHARGEABLE IPG

    MDR report key: 2201187 · Received July 29, 2011

    Report

    Report Number
    1627487-2011-07006
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 28, 2011
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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

    THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED ON (B)(6) 2011 BY THE PT, HE WAS NEAR AN MRI MACHINE IN THE MRI ROOM. WHILE IN THE MRI ROOM, HE FELT HIS STIMULATION TURN ON AND DEMANDED TO BE TAKEN OUT OF THE MRI ROOM IMMEDIATELY. PT TURNED STIMULATION OFF WITH HIS MAGNET. HOWEVER, SINCE THE INCIDENT, THE PT HAS BEEN FEELING HIS STIMULATION "SURGE" 1-2 TIMES PER WEEK. THE STIMULATION LEVEL DECREASES TEMPORARILY AND THEN RETURNS TO ITS ORIGINAL LEVEL. THE PT'S STIMULATION COVERAGE HAS NOT CHANGED. IMPEDANCES ARE ALL NORMAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16 - CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2897074

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3219