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Defective Medical Device
On October 15, 2007, Medtronic removed its Sprint Fidelis heart defibrillator cardiac leads from the market after reports that linked the devices to patient deaths. These leads monitor the rhythm of the heart and will deliver an electric shock to the heart if it begins to bear dangerously fast.
The leads in question may break down and deliver unnecessary, painful, and life-threatening shocks to people who have them implanted, or may not operate at all. You can get additional information by contacting our office or logging onto our Web site at www.attorneylewis.com.
The Medtronic recall exposes gaps in medical safety. Medical devices are regulated under different standards than are medicinal drugs. Whereas drugs must undergo testing in human trials, devices such as the Sprint Fidelis undergo less scrutiny because they are considered as changes to existing products. Also, the FDA does not mandate follow-up studies after the product is placed on the market.
If you or someone you care about has suffered serious harm or death as a result of a heart device misfiring or failing to work, call our law firm for a free evaluation at 1-877-529-9969 or 610-520-7333.
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Surveyed Hospitals: Only 10-30% use successful CA-UTI prevention practices
A recent national survey of urinary tract prevention infection practices revealed that more than 50% of hospitals did not have a monitoring system for patients with indwelling catheters and greater than 70% did not monitor the duration the catheter was in place. Read more...
Medtronic Heart Devices
On April 16, 2004, the FDA announced the recall of numerous implantable defibrillators manufactured by Medtronic, Inc., which were implanted in 1997 and 1998. Read more...
Defective Medical Device
On October 15, 2007, Medtronic removed its Sprint Fidelis heart defibrillator cardiac leads from the market after reports that linked the devices to patient deaths. Read more... |
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