BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4013093 · Received August 11, 2014

    Report

    Report Number
    1627487-2014-23526
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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 REPORTED HE HAS NOT USED OR CHARGED HIS IPG IN APPROXIMATELY 1.5 TO 2 YEARS, AS HE DID NOT NEED THE STIMULATION. THE PATIENT NOW FEELS A NEED FOR STIMULATION. HOWEVER, THE PATIENT IS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HIS IPG AND CHARGER. THE PATIENT MAY UNDERGO SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475829 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 50701

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other SCS LEAD: MODEL 3186| IMPLANT DATE: