medtronics rep came into the room and read the device. told us it shocked me 22 times in 53 minutes. he added that it was an electrical problem, electrical wire lead problem. not the device. # we had several doctors come in later that day and came into the room. one of them told my wife and i how lucky we were that i had not wrecked the car, because i had been driving. the lead replacement surgery for scheduled for monday, july 2nd, early afternoon. i was admitted for three days from saturday to tuesday, and i was discharged around noon on july the 3rd. mary drove us on to our son's house and the entire way back to our house in bettendorf. after this episode i found driving on freeways, highways, interstates, made me very anxious, made me very tense and fearful of the device going off. i was afraid i might wreck some other car, hit somebody, kill myself, et cetera. this anxiety had a huge impact on me and my job. i'd been a golf irrigation specialist for the distributor that covered 77 counties in iowa, 17 in illinois, three in wisconsin.

maisel, is it not true that after medtronic started receiving reports, you state it was within months of initial market release, they did not recall until three years later, fda inspection report cited them for objectionable conditions, failing to implement appropriate directed and preventive action procedures related to the company's investigation of the product anomaly. dr. maisel, do you believe the fda approval process is so good that manufacturers of these devicess should receive immunity when they are faulty or cause injuries? you have been there. tell us about it. >> the fda does an exceptional job of evaluating medical devices and they are extremely thorough. the biggest issue i have is this concept and manufacturer liability stops device approval. i tried to outline in my testimony all the responsibilities of a manufacturer after the fda approves their device, there is now manufacturing the product, they have to ensure stability. there are many compliance guidelines they need to follow for manufacturing. it is simply impossible for the fda to monitor individual companies when

medtronic, one of the stories of the day reporting a big decline. net profit because of a one-time charge, profits are down 38%. the company made $445 million after the company made $400 million to abbott labs in a patent infringement lawsuit. revenue was up 6%" company generated $3.9 billion in revenue. breaking down the numbers in a first on cnbc is bill hawkins, chairman and ceo of medtronics. welcome. >> thank you, maria. >> can you characterize the quarter for news. >> a solid first quarter for us. we had a balanced performance across all of our businesses, you're cardiovascular business was strong, neuromodulation, diabetes, our searchable technologies and the cardiac rhythm and spine business which in the last couple of quarters have been under some pressure. we saw good solid perform tlns. international was up 16%. so a good solid quarter. >> want to ask you about international for sure. but let me ask you about the payment to abbott labs, $400 million to resolve that patent infringement suit. is that situation fully resolved at this point?

medtronic said rep came into the room and read the device. he told us that it shocked me 22 times in 53 minutes. he added that it was an electrical wire lead problem, not the device. we had several doctors come in later that day, came into the room. one of them told my wife and i how lucky we were that i had not wrecked the car. the lead replacement surgery was scheduled for monday, july 2nd. early that afternoon i was admitted and i was discharged. mary drove us on to our sons house and the entire way back to our cars -- our house. after this episode i found that treat driving on interstates and highways made me very anxious. it made me very tense and fearful of the device going off. i was afraid i might wreck some other cars, hit somebody, kill myself, etc.. this anxiety had a huge impact on me and my job. i had been an irrigation specialization -- specialist for 77 counties in iowa and other states also. that is a lot of driving. i was no longer able to do my job. it also affected my personal life, this inability to drive. i had annual fis

check our timeline, medtronic actually started getting complaint in 2005., and by 2006, it knew it had a serious problem. but, it didn't recall the device until october 2007. by early 2008, the company faced at least 2,000 lawsuits, and then in february, 2008 medtronic was suddenly off the hook. the u.s. supreme court ruled that under current federal law, medtronic could not be sued because its device had originally been approved by the fda. suddenly, fell lis's lawsuit and thousands of others stopped cold. >> many of the medical devices have been changed or fixed or improved, because of actions by the courts. >> reporter: congressman frank pa lone supports a will to let people like phyllis sue companies like medtronic and a medtronic spokesperson says among patients at high risk of sudden cardiac arrest more than 95% will die without a defibrillator but with one more than 98% will live and that lawsuits would stifle innovation and instead, he says the fda will be the arbiter and it can do better and use more resources, we think that is where the focus of c

maisel, about medtronics. if they wanted those materials they would have gotten them. i don't know the reason behind it. maybe they did in the end. one concern i and others had deals with the mission of the fda with regard to medical devices. the current regulatory system, the device manufacturers have to go through an extensive review process and analysis from top experts in the fda and elsewhere, they have to strictly adhere to the fda at labeling and marketing requirements, even after the devices on the market, they have to report back to the fda on the implementation and use of the device including any adverse events. what we are dealing with is a bar that has already been set exceptionally high. this legislation allows panels of randomly selected jurors with no expertise at all in the field, or any aspect of it, to overrule this entire process and won't create new standards of suitability and market readiness for medical devices. does this legislation not suggest -- let me ask you this, mr. hutt, does this suggest a jury of 12 layman is better able to determine th

is it not true that after medtronic received reports of these manufacturers, you state that within monthsf initial market release they did not recall it until three years later an fda report said there was "objectionable conditions" related to the company investigation of the product anomaly. do you believe the fda approval process is so good that manufacturers of these devices should receive immunity when there faulting or cause injuries? you have been there. tell us about their. >> efta has done an exceptional job evaluating devices. they are thorough. the issue i have is the concept that manufacturer liability stops that device approval. i tried to outline all the responsibilities of the manufacturer after the fda approves the device. they have to ensure stability. there are many compliance guidelines that they need to follow. it is simply impossible for the fda to monitor individual companies when there are 50,000 manufacturers and 100,000 devices such being produced. the idea that only those companies that get caught by the fda for the one sector going to be held liable is bad policy

. >>> medtronic, revenues were a little heavy this time. 3.93 versus street 3.8, as you can see.e you ever shopped there? >> what do they sell? >> women's clothes -- >> oh, i'm there. >> they had earnings ten cents ex-items versus previous guidance of nine to ten cents. margins -- gross margin, 55% versus 52% year over year. so they improved. we'll do staples. we talked to john mahoney any, cfo, who had not such encouraging things to say. >>> when we come back this morning, what does the banking industry think about the president's move to renominate bernanke to a second term as fed chief? and the regulation revolution. delaware senator ed coffman wants an fcc overhaul of the markets. fithe same tools the pros use, so you can be a disciplined trader. by selecting from eight advanced triggers, your order gets executed, even when you're busy. and with trailing stops to help you lock in profits and minimize risk, you can be confident in your strategy, no matter which way the market moves. find out why more and more active traders are turning to fidelity for a smarter way to trade on

we're going to get numbers today from the likes of bookstore chain borders, burger king, had i co's, medtronic, staples and that is your global stock watch. maura. >> cash for clunkers has been good to toyota. it's paid off, in fact. the japanese carmaker is set to boost output in november. is this a temporary gear change? >> plus, big ben holds on to his job. we'll assess what this means for the future of policy. stay tuned. ííííííííííí >>> i'm mike huckman 37 in the united states, president obama will tap ben bernanke for a second term as fed chairman, keeping him in place to steer the world's biggest economy out of recession. >> i'm maura fogarty. here in asia, news about mr. bernanke fails to lift major markets. major markets and shanghai all in the red. >> i'm becky meehan. markets remain lower despite germany returning to growth in the second quarter. >> let's take a look at global markets. the ftse cnbc global 300 is down 0.3% the last time we checked. as far as the european bourses are concerned, we have seen a bit of a pullback in the european markets today and that appears