BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012219 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-06041
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORY. 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: 1627487-2013-06042. IT WAS REPORTED THE PATIENT EXPERIENCED POCKET HEATING WHILE CHARGING AND DEVELOPED BLISTERS OVER THE IPG SITE. THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO THE BURNING SENSATION. A NEW LOW ENERGY CHARGER WAS SENT TO THE PATIENT TO ADDRESS THIS ISSUE. THE PATIENT WAS ALSO INSTRUCTED TO WAIT AND LET HER BURN HEAL BEFORE USING THE NEW CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104277 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3486479

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R IMPLANT:| SCS LEAD: MODEL 3228