BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4060293 · Received August 25, 2014

    Report

    Report Number
    1627487-2014-26676
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 4, 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 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

    THE PATIENT IS IMPLANTED WITH A THORACIC AND A CERVICAL SCS SYSTEM AND THIS REPORT DETAILS THE CERVICAL SYSTEM. IT WAS REPORTED THE PATIENT HAS NOT USED OR RECHARGED HER IPG IN OVER TWO YEARS THUS HER IPG IS INOPERABLE. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513571 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 49110

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS LEAD, MODEL: 3146 (2)| SCS EXTENSION, MODEL: 3383| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION, MODEL: 3343| IMPLANT DATE:| SCS LEAD, MODEL: 3186