BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110798 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02622
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBERS: 1627487-05242011-002-R, 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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 3. REFERENCE MFR REPORT: 1627487-2013-02623 AND 02624. IT WAS REPORTED THE PT EXPERIENCES PAIN AFTER CHARGING AND UNCOMFORTABLE POCKET HEATING DURING CHARGING. A NEW LE CHARGING SYSTEM WAS SENT TO THE PT, BUT HE STATED HE HAD NOT TRIED USING IT YET DUE TO THE PAIN HE FEELS AFTER CHARGING. HE REPORTED AFTER CHARGING, HE FEELS A DEBILITATING PAIN IN HIS LOWER BACK AND LEGS WHICH CAN LAST UP TO A WEEK. HE STATED TURNING STIMULATION ON HELPS THE LEG PAIN BUT THE LOW BACK PAIN PERSISTS. HE ALSO REPORTED A RANDOM, ACHING PAIN IN THE AREA OF HIS THORACIC INCISION SITE WHICH RADIATES AROUND HIS RIB CAGE. IN ADDITION, THE PT REPORTED HE GETS "SURGES" OF STIMULATION WHEN HE CHANGES POSITIONS AND ADJUSTING THE AMPLITUDE DOES NOT RESOLVE THE ISSUE. THE PT ALSO ALLEGED HE OCCASIONALLY EXPERIENCES A LOSS OF MOTOR CONTROL OR MUSCULAR RIGIDITY OF HIS LEFT LEG. IT WAS REPORTED THE PT HAS AN APPOINTMENT WITH HIS PAIN MANAGEMENT CLINIC TO ADDRESS THE ISSUES AT A LATER DATE. ON (B)(4) 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
    204723 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2897074

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention