BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 2080365 · Received April 22, 2011

    Report

    Report Number
    1627487-2011-02479
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL ANALYSIS NOTED SEPTUM DAMAGE, PEELING PARYLENE, A DENTED CAN AND INSTRUMENT MARKS ON THE ANTENNA COVER. NO SHARP BENDS OR OTHER VISUAL ANOMALIES THAT WOULD RESULT IN PAIN WERE NOTED. PRELIMINARY FUNCTIONAL TESTING FOUND DAMAGE TO THE BAL-SEAL SPRING IN THE LOWER HEADER PORT. AS A RESULT, FUNCTIONAL TESTING COULD NOT BE COMPLETED. 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 RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2008. IT WAS REPORTED THE IPG WAS EXPLANTED AND REPLACED WITH A SMALLER MODEL DUE TO PAIN AT THE IPG POCKET AND INTERMITTENT TELEMETRY. ACCORDING TO THE PATIENT'S HEALTH CARE PROFESSIONAL, THE PATIENT HAD LOST WEIGHT SINCE THE IPG WAS IMPLANTED WHICH MAY HAVE CONTRIBUTED TO THE TELEMETRY ISSUES AND OVERALL POCKET DISCOMFORT. NO FURTHER PATIENT 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 113550

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention