BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3133226 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-03678
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    THE PATIENT REPORTED SHE IS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER SCS IPG AND MULTIPLE CHARGING SYSTEMS AFTER NOT CHARGING FOR APPROXIMATELY 2 MONTHS. SUBSEQUENTLY, THE PATIENT IS NO LONGER RECEIVING STIMULATION. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223210 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3218920

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3183| SCS LEAD, MODEL 3186