BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3033139 · Received April 1, 2013

    Report

    Report Number
    1627487-2013-04392
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 8, 2013
    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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO TURN THE IPG OFF USING THE MAGNET. THE PATIENT REPORTED HE HAD PURCHASED A MAGNET FROM A HARDWARE STORE, BUT THIS MAGNET HAD STOPPED WORKING FOR HIM. A REPLACEMENT MAGNET WAS SENT TO THE PATIENT, AND INSTRUCTIONS WERE PROVIDED REGARDING THE USE OF THE MAGNET. FOLLOW UP IDENTIFIED THE REPLACEMENT MAGNET DID NOT RESOLVE THE ISSUE. THE PATIENT REPORTED THE MAGNET WOULD ONLY TURN THE STIMULATION OFF. FOLLOW UP IDENTIFIED THE PATIENT WAS REPROGRAMMED AND THE MAGNET WAS ABLE TO TURN THE SCS SYSTEM ON USING THE MAGNET, BUT NOT ABLE TO TURN THE SYSTEM OFF WITH THE MAGNET. IT WAS REPORTED THE PATIENT WAS SATISFIED WITH USING THE PROGRAMMER TO TURN THE SYSTEM OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132273 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3088838

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)