BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2894943 · Received December 20, 2012

    Report

    Report Number
    1627487-2012-15091
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND 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 #: 1627487-2012-15092. IT WAS REPORTED THE PATIENT WAS EXPERIENCING HEATING AT THE IPG POCKET SITE WHILE CHARGING THE IPG. THE PATIENT INDICATED SHE CHARGED ONCE A WEEK FOR 4 TO 6 HOURS. THE PATIENT WAS ADVISED TO CHARGE MORE OFTEN. FOLLOW-UP INDICATED THE PATIENT WAS SENT A REPLACEMENT CHARGER. THE SCS REP IS TO MEET WITH THE PATIENT AS THE NEXT COURSE OF ACTION. 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
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2777973

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention SCS LEAD, MODEL 3186 (2)| IMPLANT DATE: