BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1617457 · Received February 25, 2010

    Report

    Report Number
    1627487-2010-00046
    Event Type
    Injury
    Date Received
    February 25, 2010
    Date of Event
    January 19, 2010
    Report Date
    January 27, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION 2 OF 2 (REFER TO MFR'S REPORT NUMBER 1627487-2010-0045 FOR DEVICE 1). RESULTS: THE IPG PASSED AUTO TESTING AND COMMUNICATION TESTING WITH THE PT PROGRAMMER. THE VISUAL INSPECTION REVEALED THAT THE IPG WAS FREE FROM ANY VISUAL ANOMALIES. CONCLUSION: THE REQUEST TO EVALUATE THE PARYLENE SHOWED THAT THE DEVICE WAS WITHIN SPECIFICATION. LOT NUMBER RESEARCH ON THE IPG INDICATED THAT THE THICKNESS FOR THE PARYLENE COATING WAS ACCEPTABLE. ANS 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. (REFER TO MFRS REPORT NUMBER 1627487-2010-0045 FOR DEVICE 1). IT WAS REPORTED, THAT A PT WITH A HISTORY OF SILICONE ALLERGIES, WAS IMPLANTED WITH TWO EON IPGS. THE PT'S INCISIONS APPEARED RED AND INFLAMED. BOTH IPGS WERE EXPLANTED. THE PHYSICIAN REMOVED THE DEVICES WITH FORCEPS. NO SIGNS OF INFECTION WERE PRESENT AND BOTH SITES WERE SWABBED FOR CULTURES. THE PHYSICIAN REQUESTED THAT THE IPGS PARYLENE BE EVALUATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 96905

    Patients

    Seq Age Sex Outcome Treatment
    1