BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052830 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-06128
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-12192011-003-R, 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND 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

    DEVICE 2 OF 2. REF MFR REPORT #1627487-2013-06120. IT WAS REPORTED THE PT VISITED THE EMERGENCY ROOM BECAUSE HIS STIMULATION WAS SHOCKING HIM AND HE COULD NOT SHUT IT OFF USING THE MAGNET. A SJM REP WAS CONTACTED AND MET WITH THE PT AT THE HEALTH FACILITY AND VERIFIED THE SCS SYSTEM WAS TURNED OFF AND FUNCTIONING CORRECTLY. THE SYSTEM RESPONDED TO NORMAL PROGRAMMING AND THERE WAS NO SHOCKING OBSERVED. THE REP INFORMED THE PHYSICIAN THE SYSTEM WAS TURNED OFF AND FUNCTIONING CORRECTLY. NO FURTHER ACTION WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135473 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2880146

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention