BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 2080405 · Received April 22, 2011

    Report

    Report Number
    1627487-2011-02468
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    DEVICE 1 OF 6. REFERENCE MFR REPORT: 1627487-2011-02469, 1627487-2011-02470, 1627487-2011-02471, 1627487-2011-02472 AND 1627487-2011-02473. THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, FOUR PERCUTANEOUS LEADS AND AN EXTENSION, ON (B)(6) 2010. IT WAS REPORTED THE SCS SYSTEM WAS EXPLANTED AND NOT REPLACED DUE TO INADEQUATE PAIN RELIEF. MULTIPLE REPROGRAMMING ATTEMPTS WERE UNABLE TO RESOLVE THE PT'S PAIN. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 3071746

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention