BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON C 16-CHANNEL IPG

    MDR report key: 2030936 · Received March 22, 2011

    Report

    Report Number
    1627487-2011-00334
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PATIENT WAS IMPLANTED WITH AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT DURING AN EXPLORATORY PROCEDURE FOR A PREVIOUSLY REPORTED LEAD ISSUE, THE PATIENT'S IPG WAS REPLACED DUE TO A LOOSE PORT PLUG. FOLLOWING THE PROCEDURE, IMPEDANCE PROBLEMS PERSISTED. AS A RESULT, THE PATIENT'S LEAD WAS REPLACED (REFERENCE MFR REPORT # 1627487-2011-00220). THE EXPLANTED IPG WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON C 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3688 3093200

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention