BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3524711 · Received November 1, 2013

    Report

    Report Number
    1627487-2013-07507
    Event Type
    Injury
    Date Received
    November 1, 2013
    Date of Event
    October 10, 2013
    Report Date
    October 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    IT WAS REPORTED THE PT WAS UNSATISFIED WITH THE LOCATION OF THE IPG. IT WAS REPORTED THE PT WAS RECEIVING EFFECTIVE STIMULATION, BUT WANTED THE IPG TO BE REPOSITIONED AWAY FROM HER RIBS, SINCE IT TOUCHES THE RIB WHEN SHE SITS DOWN. THE PT WAS TO MEET WITH THE PHYSICIAN REGARDING THE NEXT STEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564034 EON MINI GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4120909

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3228