BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 2091601 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-02506
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 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 INSPECTION NOTED SOME INSTRUMENT MARKS ON THE SILICONE ANTENNA COVER. FUNCTIONAL TESTING FOUND THE IPG WAS DEPLETED IN A MANNER CONSISTENT WITH THE PATIENT'S NONCOMPLIANCE WITH THE IPG RECHARGING REQUIREMENTS. 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

    DEVICE 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-02507. THE PATIENT RECEIVED AN SCS SYSTEM WHICH INCLUDED AN IPG AND TWO PERCUTANEOUS LEADS (OF THE SAME LOT). IT WAS REPORTED THE IPG WAS EXPLANTED AND REPLACED DUE TO BATTERY DEPLETION AND A SUBSEQUENT LOSS OF STIMULATION. THE PATIENT INDICATED SHE HAD NOT RECHARGED HER IPG IN OVER 12 MONTHS. THE PATIENT'S LEADS WERE TESTED INTRAOPERATIVE AND IMPEDANCES ACROSS ALL CONTACTS WERE HIGH. AS THE PHYSICIAN WAS ABLE TO ACHIEVE STIMULATION DESPITE THE HIGH IMPEDANCES, THE LEADS REMAIN IMPLANTED AND IN USE. NO 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 48406

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention