BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1882809 · Received October 13, 2010

    Report

    Report Number
    1627487-2010-02761
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: A VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE VISUAL INSPECTION REVEALED THAT THE IPG BOTTOM SEPTUM WAS LOOSE AND THE SETSCREW WAS MISSING. THE TOP SETSCREW WAS DISPLACED AND HAD TO BE SECURED BACK. THE IPG WAS TESTED ON THE AUTO-TESTER AND PASSED. SEVERAL LAB LEADS WERE SUCCESSFULLY INSERTED INTO BOTH HEADERS. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE COMPLAINT COULD NOT BE CONFIRMED FOR "CAN'T INSERT LEAD FULLY." SEVERAL LAB LEADS WERE SUCCESSFULLY INSERTED INTO BOTH HEADERS. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFO 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS IMPLANTED WITH A PERMANENT SCS SYSTEM. PRIOR TO THAT, THE PT HAD A LEAD IMPLANTED FOR THE TRIAL THAT WAS CONNECTED TO AN EXTENSION, WHICH WAS EXTERNALIZED TO THE MTS. DURING THE PERMANENT IMPLANT PROCEDURE, THE DOCTOR REMOVED THE EXTENSION, AND ADDED THE IPG TO THE EXISTING LEAD. THE DOCTOR HAD DIFFICULTY INSERTING THE LEAD TO THE BOTTOM HEADER. WHEN HE WAS FINALLY ABLE TO INSERT THE LEAD, THE LEAD EXHIBITED HIGH IMPEDANCES. THE LEAD WAS INSERTED INTO THE TOP HEADER WITHOUT ANY DIFFICULTY AND EXHIBITED NORMAL IMPEDANCES ON ALL CONTACTS (AROUND 700 OHMS). THE DOCTOR REMOVED THE LEAD FROM 1-8 AND WHEN HE TRIED TO REINSERT IT, THE DOCTOR COULD ONLY GET THE FIRST 6 CONTACTS INSIDE THE HEADER. THE DOCTOR ASKED FOR A NEW IPG. THE LEAD WAS INSERTED INTO BOTH HEADERS OF THE NEW IPG WITHOUT DIFFICULTY. THE ORIGINAL IPG WAS NEVER IMPLANTED INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 3131344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other