BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3891832 · Received June 10, 2014

    Report

    Report Number
    1627487-2014-26501
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    PATIENT REPORTED SHE IS WITHOUT STIMULATION AND IS UNABLE TO RECHARGE HER IPG. SHE HAS BEEN UNABLE TO COMMUNICATE WITH HER CHARGING SYSTEM, HOWEVER HER IPG CAN COMMUNICATE WITH THE PROGRAMMER. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT WHICH DID NOT RESOLVE THE ISSUE. THE PATIENT STATED SHE RECENTLY GAVE BIRTH AND THE ISSUE BEGAN AFTERWARDS. THE SJM REPRESENTATIVE IS TO MEET WITH THE PATIENT AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338841 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3434519

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3186