BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3022448 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-12375
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-20192011-003-R
    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

    IT WAS REPORTED THE PATIENT'S SYSTEM IS TURNING OFF WITHOUT PROMPTING. THE SJM REPRESENTATIVE INTERROGATED THE SYSTEM AND FOUND NO ANOMALIES. THE PATIENT WILL KEEP A DIARY OF OCCURRENCES AND FOLLOW-UP WITH THE SJM REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119879 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3199437

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: