posts from hell
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in the USA alone there has been MORE than 500 explanations since 5/5/2010....
what gives?
what gives?
Can you elaborate?
How? What more info do you need?
500 explanations on what? CIs?
500 CI's were removed from human beings since 5/5/10.
what did they fill the cavity with?
500 CI's were removed from human beings since 5/5/10.
It was reported that the patient was bilaterally implanted in (b)(6) 2010 with sonata devices. The surgeon's medical report dated (b)(6), 2010, stated that child had an infection around his left cochlear implant for about one month. He was then scheduled for an explant on (b)(6), 2010. The physician did not contact med-el about this explant beforehand, so an explant kit had not been shipped or surgical support arranged to be present. The device has been discarded as biohazard waste and will not be returned to med-el.
Really? geez!
things like this makes me cringe.....
Per the clinic, the device was explanted (b)(6), 2010 due to improper electrode placement. The patient was reimplanted with a new device during the same surgery.
Where do you get that information?
The company was made aware that the pt has an open wound at the implant site and the implanted device is exposed. It was reported that the pt's external equipment's magnet was too strong. The pt has lost a lot of weight and is undergoing medical care for issues that are not device related. The pt has discontinued wearing the external equipment. The pt is currently being monitored.
online.
another one... wow..Per the clinic, the device was not inserted in the cochlea resulting in the decision to explant the device. The device was explanted (b)(6), 2010, and the patient was reimplanted with a new device during the same surgery.
And will you support that claim?
should I?
I actually do have access to the FDA site that you are pulling this from, but I think it is only right that you share it, so that you can back up what you are saying.