Download MSD 1015 - Docket Alarm

1, David Hacker of Duval County, Jacksonville, Florida, declare that:
1.
I am the Principal Engineer, Research and Development, for Medtronic, Inc.,
in the Surgical Technology Division. I have worked as an engineer on Nerve
Integrity Monitor (NIM) systems for surgical applications since 1989.
Specifically, from 1989 to 1999, I worked on NIM systems for Xomed, Inc. In
1999, Xomed, Inc. was acquired by Medtronic, Inc. I have continued to work on
NIM systems for Medtronic, Inc. since that acquisition.
2.
My work on NIM systems has involved reviewing user manuals that are
provided with the NIM products sold by Medtronic, Inc. (and previously Xomed,
Inc.). These user manuals are shipped with the corresponding product to
customers who buy the product.
3.
Being submitted with this Declaration as Attachment A is one such manual,
which is entitled NIIVI-Response — Nerve Integrity Monitor/Intraoperative EMG
Monitor — User’s Guide (“User Guide”). The User Guide was a user manual for
the NIM-Response 82-50001 Mainframe product (“NIM-Response product”) and
was shipped with the product to customers.
4.
The User Guide has a copyright date of 2000 on the page following the title
page. I note that the User Guide has a date of “03/00” on the last page. This
indicates that this version (Revision B) of the User Guide was finalized in March
2000. The User Guide also has a handwritten “4/4/2000” notation at the top of the
title page. This indicates that the User Guide was approved for release with the
corresponding product on April 4, 2000.
5.
In addition, I have attached a copy of a Work Order for the NIM-Response
product as Attachment B to this Declaration. Work orders document the date that a
product was built and includes, among other things, the first and last page of the
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