Corpus Christi Personal Injury Lawyer - Medical Devices & Implants

Medtronic Brain Device Approved For OCD Treatment

Chrissie Cole — Thu, 19 Feb 2009 12:57:00 GMT

The U.S. Food and Drug Administration (FDA) has approved Medtronic’s deep brain stimulator designed to help treat patients that suffer from severe obsessive-compulsive disorder, or OCD.

OCD is estimated to affect one in 50 adults in the United States. Medtronic said the Reclaim DBS will likely only be appropriate for use in less than 4,000 patients.

The device, Reclaim DBS therapy, a pacemaker-like device attached to four electrodes that deliver electrical jolts to brain areas that regulate mood and anxiety, was approved on Thursday under the FDA’s humanitarian device exemption policy, the agency said.

Under such approvals, Medtronic is required to show the device was safe and offered “probable benefits.”

The Reclaim DBS therapy will be available to a small group of OCD patients that have not responded to other treatment options.

Originally posted at InjuryBoard by Chrissie Cole

FDA Announces Class 1 Recall of AEDs

Chrissie Cole — Thu, 11 Sep 2008 09:32:00 GMT

Physio Control Inc., issued a Class 1 recall of LifePack CR Plus Automated External Defibrillators (AED), used to treat adult patients in cardiopulmonary arrest.

The device works by instructing the responder, via voice prompts, to press the shock button. However, the button is covered and not clearly visible and therefore the responder is unable to receive shock therapy when needed.

The FDA recommends the AED device removal from service, or the manufacturer-provided diagram can be help assist the patient to remove and discard the shock button cover.

249 devices manufactured from May 20, 2004 through August 11, 2997 have been affected by the recall.

Customers with questions may visit the following website for more information or to enter the serial numbers of their devices to determine if they have a recalled device that is affected by the recall. Customers may also call Physio-Control Technical Support at 1-800-442-1142, option 5, between 6:00 a.m. and 4:00 p.m. (Pacific Time).

Originally posted at InjuryBoard by Chrissie Cole

Dialysis Catheter Recalled by AngioDynamics

Chrissie Cole — Sun, 13 Jul 2008 21:50:00 GMT

AngioDynamics Inc, medical device maker, is voluntarily recalling its Centros dialysis catheter due to a possible manufacturing defect.

The cuff on the device, which is used to anchor the catheter during dialysis procedures, was inadequately attached in some instances. That allowed the entire catheter to move, causing leakage around the site, or left the cuff inside the insertion site when the catheter was removed in some cases.

The defect is likely due to a manufacturing defect, the company said.

Shipments of Centros are expected to continue during the company’s fiscal third quarter, pending FDA review, said the company in a statement.

Since January, the company has shipped about 1,500 catheters as part of a limited launch. To date, the number of instances reported is less than 1 percent of those shipped products.

Hospitals, patients and physicians with product related questions can contact AngioDynamics customer Service directly at 1-800-772-6446.

Originally posted at InjuryBoard by Chrissie Cole

Spohn South Overdoses 14 Infants With Heparin

Jesse Guerra / Texas Safety Lawyer — Tue, 08 Jul 2008 17:40:27 GMT

According to the Corpus Christi Caller Times, Christus Spohn Hospital South staff are investigating how 14 premature babies received overdoses of the controversial drug Heparin. The drug is widely used to flush intravenous lines to prevent blood clots from forming.

Hospital officials discovered the problem after nurses noticed abnormal lab tests that were done on the infants. Two babies were released and twelve babies were being closely monitored as of Sunday night.

The overdoses may lead to serious injury and even death.
Officials believe that a mix-up in the pharmacy there may have played a part in the compounding of the dosage amounts received by the infants.

Heparin has received national attention in the New York Times, Wall Street Journal, and LA Times News Journals. Actor Dennis Quaid's new born infants received overdoses of the drug in November 2008 receiving national attention that prompted legislative action and national media attention as seen on 60 Minutes.

Congress has had two Congressional hearings on the drug recently to investigate numerous injuries, complications, and fatalities associated with the drug.

Originally posted at InjuryBoard by Jesse Guerra / Texas Safety Lawyer