BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2800853 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-02525
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 25, 2012
    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

    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 HAS THORACIC AND CERVICAL SCS SYSTEMS. IT WAS REPORTED THE PATIENT WAS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER THORACIC IPG AND CHARGER AND CONSEQUENTLY SHE LOST STIMULATION. THE PATIENT STATED SHE HAD NOTICED CHARGING GRADUALLY HAD BECOME MORE DIFFICULT. A SECOND CHARGING SYSTEM WAS UNABLE TO RESOLVE THE ISSUE. IT WAS REPORTED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3206173

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3383 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3228| IMPLANT DATE:| SCS IPG: MODEL 3716| SCS LEAD: MODEL 3228