BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3022391 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-03403
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    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 A 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

    IT WAS REPORTED THE PATIENT WANTS HIS SCS IPG EXPLANTED. FOLLOW-UP IDENTIFIED THE PATIENT IS EXPERIENCING RIB PAIN AND THE PHYSICIAN WANTS THE SCS IPG EXPLANTED IN ORDER FOR THE PATIENT TO HAVE AN MRI. ON (B)(6) 2013 FOLLOW-UP IDENTIFIED THE PATIENT'S SCS IPG WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119597 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3497925

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT:| IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1194| SCS LEAD: MODEL 3228| SCS ANCHOR: MODEL 1192