BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3031903 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-03422
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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 1 OF 2: REFERENCE MFR. REPORT: 1627487-2013-03423. THE PATIENT REPORTED SHE IS NOT RECEIVING STIMULATION DUE TO NOT CHARGING HER SCS SYSTEM AFTER MISPLACING HER CHARGING SYSTEM. ADDITIONALLY, THE PATIENT REPORTED EXPERIENCING HEATING AT HER SCS IPG POCKET SITE WHILE CHARGING HER SCS SYSTEM PRIOR TO NO LONGER CHARGING. SUBSEQUENTLY, A REPLACEMENT CHARGING SYSTEM (LOW ENERGY) WAS SENT TO THE PATIENT. FURTHERMORE, THE PATIENT WAS ADVISED OF CHARGING RECOMMENDATIONS. FOLLOW-UP IDENTIFIED, THE ISSUES WERE RESOLVED WITH THE REPLACEMENT CHARGING SYSTEM. ON (B)(4) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. 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
    127729 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3491247

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCS LEAD: MODEL 3189 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)