BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3101937 · Received May 6, 2013

    Report

    Report Number
    1627487-2013-04547
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL #: 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND A FIELD CORRECTION. 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 2. REFERENCE MFR REPORT: 1627487-2013-04548. THE PT REPORTED THE CHARGING ANTENNA BEGAN TO GET HOT WHILE RECHARGING THE IPG. IT WAS REPORTED SHE BEGAN TO USE THE CHARGING POUCH IN ORDER TO RECHARGE THE IPG. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. FOLLOW UP IDENTIFIED THE PT RECEIVED THE REPLACEMENT CHARGING SYSTEM AND THE ISSUE WAS RESOLVED WITH THE NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197237 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3143588

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SCS LEAD: MODEL: 3228| IMPLANT: