Why didn Medtronic report Nesbits death?
That’s a question the FDA wants answered – especially after it sent Medtronic a warning letter last year informing the company that it had failed to report numerous adverse events in its neuromodulation business – something it is required to do. The FDA requires all medical device and drug manufacturers to report adverse events about their products and recommends that manufacturers follow up with hospitals and patients about such events at least three times. However in Nesbit’s case, Kaiser Permanente said that it did not report her death to Medtronic because it did not believe that the manufacturer’s product caused her death – which is something that will likely be left to a jury to decide. If you’ve been injured due to a defective or dangerous product, contact an experienced medical device recall attorney to discuss your case and evaluate your options. Consultations with an attorney are free, without obligation and are strictly confidential.
