BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 2051343 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-02413
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT REC'D HER SCS SYS, INCLUDING AN IPG, ON (B)(6) 2008. IT WAS REPORTED THE PT'S SCS SYS IS INTERFERING WITH HER CARDIAC IPG. ALTHOUGH THE SCS SYS IS A CONTRAINDICATION FOR PTS WITH A CARDIAC IPG, THE PT HAS DECLINED TO HAVE THE SCS SYS EXPLANTED. SHE IS WORKING CLOSELY WITH HER PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 97932

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention