BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1904383 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02193
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    December 9, 2008
    Report Date
    December 9, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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. IPG AS RETURNED IS NON-FUNCTIONAL AND FAILS AUTO TEST. 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 5. REFERENCE MANUFACTURER REPORT 1627487-2010-02194, 1627487-2010-02195, 1627487-2010-02196 & 1627487-2010-02197. THE PT RECEIVED HER SCS SYSTEM, WHICH INCLUDED FOUR PERCUTANEOUS LEADS (FROM THREE SEPARATE LOTS), TWO DUAL LEAD EXTENSIONS (FROM THE SAME LOT) AND AN IPG, ON (B)(6) 2007. SIX MONTHS LATER, THE PT UNDERWENT HEART SURGERY. SINCE THEN, THE PT'S SCS SYSTEM HAD REPORTEDLY BEEN NONFUNCTIONAL. ADDITIONALLY, THE IPG COULD NOT BE CHARGED AND THE IMPEDANCES ON ALL FOUR LEADS WERE LOW (APPROX 70 OHMS). THE ENTIRE SCS SYSTEM WAS EXPLANTED ON (B)(6) 2008. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES OR IMPLANTS. THE EXPLANTED SCS SYSTEM WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3716 64921

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention