FDA Warns Medical Device Maker about Safety Problems

by Ryan L. Thompson on 01/23/2013

The Food and the Administration has warned medical device manufacturer St. Jude Medical about several safety issues at a plant which manufactures implantable heart defibrillators.

The plant in question is located in Sylmar in California.   According to the company, it is trying to correct the problems that the FDA is concerned about.  In October, St. Jude Medical announced that federal inspectors had visited the plant in California, and found several safety problems.   The inspectors found problems in the manner that the company manufactured and documented cardiac defibrillators.

The new warning letter that the Food and Drug Administration has sent St. Jude Medical states that the agency will not approve any more new products, unless these problems at the California plant are corrected.  As of now, the federal administration has not asked St. Jude Medical to recall any product.  Products will be manufactured at the facility as normal.

The New York Times reports that St. Jude Medical has had several problems in recent years with the wires that are used to attach defibrillators to the heart.  Cardiac defibrillators are implantable cardiac devices that are used to rectify rhythm problems like cardiac arrhythmia.  Different devices work in different ways to correct heart rhythm, but basically, these devices detect when the heartbeat is showing irregularities and “kickstart” the heartbeat, to maintain a consistent rhythm. 

For obvious reasons, any defect in a device that is responsible for regulating heartbeat can result in severe injuries, or even death.  In fact, Texas product liability lawyers have found implantable cardiac defibrillators manufactured by Medtronic at the center of several medical injury and wrongful death lawsuits recently.

Tags: Medical Device Mass Torts, Product Liability

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