BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 1904138 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02208
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    December 11, 2009
    Report Date
    December 11, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    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

    EVAL - METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). 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 1 OF 4. REFERENCE MFR REPORT: 1627487-2010-02209, 1627487-2010-02210 AND 1627487-2010-02211. THE PT RECEIVED THEIR SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE ENTIRE SYSTEM WAS EXPLANTED ON AN UNK DATE DUE TO (B)(6) INFECTION. ACCORDING TO THE MFR'S DEVICE REGISTRATION SYSTEM, NO NEW SCS SYSTEM WAS IMPLANTED. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED. THE EXPLANTED PRODUCTS WERE DISPOSED OF AT THE FACILITY. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3688 2864587

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention