Last week, FDA issued a Class I recall on faulty St. Jude Medical Inc. defibrillators. These medical devices are implanted into patients with heart problems to control an irregular heartbeat.
The medical devices are called dual coil defibrillation leads, and are connected to St. Jude’s Implantable Cardioverter Defibrillators or ICDs. This device monitors patients who have an abnormal heartbeat, and then it delivers a pulse of electric current to restore the heartbeat to a normal rhythm.
A Class 1 recall is a serious, strict recall that is issued where the faulty medical device could lead to death or serious injury.
St. Jude Medical stated that it has advised doctors to monitor all patients who were implanted with the 445 Optisure leads that are being recalled this month.
The medical device company stated that it has yet to receive any reports of decreased performance from the affected leads. It added that a method to take off extra medical adhesive around a shock coil could have damaged the insulation that is around the Optisure leads.
St. Jude also had a class I recall back in 2010 of its Riata defibrillator leads, after there were reports of deaths and injuries from the faulty wires in the devices. Last year, the device company agreed to pay over $14 million to settle 900 legal claims related to that medical device.
This new recall due to a device manufacturing defect is sure to concern the firm’s shareholders and medical professionals who routinely work with St. Jude medical devices.
Limited Recall This Time
On the upside, this class I recall probably is not as widespread as the last one that the company experienced. St. Jude mailed recall letters to doctors in November 2015 that told them that during manufacturing processes of some Optisure leads, a trimming technique was used to remove extra medical adhesive around a shock coil that could have damaged the insulation of the lead. About ⅔ of the affected devices are in the US market.
The company noted in a recall letter that depending upon the programming of the device and how deep the cut was to the insulation, the damaged lead insulation could cause an electrical problem where the defibrillator will not be able to deliver proper high voltage therapy.
In the recall letter, the company added that it is not aware that there have been any adverse events that are related to the defect. The firm has estimated that the chance of a high voltage short happening from insulation damage is .32%.
St. Jude has advised all doctors who use the device to make sure that all patients that may have been affected are enrolled in their Merlin.net patient monitoring platform and to use the technology they call DynamicTx, which automatically adjusts the level of shock to make sure that high voltage therapy works properly even if there were a short. All but 10 patients with the faulty leads have devices that have the DynamicTX feature.
Some experts in the medical device field note that defibrillation leads used at other device manufacturers also have been faulty in the past, and have about the same number of adverse events reported as St. Jude. Those same experts stated that St. Jude tends to be very compulsive about reporting any potential adverse event. They noted that field personnel at St. Jude often will report any suspected adverse event, which could increase the total number of AEs to a higher than normal figure.
St. Jude Medical also reported at the end of January 2016 that it expected lower profits this year, due to the effects of the recall, as well as increased competition. Sales of defibrillators decreased to $580 million at the end of the last quarter.
About St. Jude Medical Defibrillators
The St. Jude defibrillator recall by FDA is significant because the company’s defibrillators are used extensively throughout the world to help heart patients of all ages. One of the things that has made St. Jude Medical Defibrillators leaders in the industry is that they feature ShockGuard technology; this protects users and patients against unnecessary and inappropriate shocks. As noted on the St. Jude Medical website, almost ⅓ of all ICD shocks are inappropriate and can cause harm in some cases. Reducing the amount and degree of shocks over time can improve quality of life.
Other innovative features included in these defibrillators:
- DecisionTx – This is programming that allows for superior discrimination of arrhythmias, which results in the best therapies for the patient.
- Far Field MD – A morphology discrimination algorithm that improves the use of near field morphology analysis, which reduces inappropriate therapies.
- Chamber Onset – A discrimination algorithm that uses atrial and ventricular interval data to diagnose the heart rhythm to determine which heart chamber is causing the arrhythmia.
- SecureSense – An RV lead noise discrimination algorithm that is able to differentiate lead noise from authentic VT/VF episodes.
Another unique aspect of St. Jude Medical defibrillators is what the company calls Patient Notifier. This feature will alert you if there are significant changes in the medical device’s performance. This lets your doctor know that the device needs attention. He or she can program the St. Jude Medical defibrillator to sense any significant changes in performance. St. Jude Medical uses two sorts of patient notifiers; one will send you a two tone audible signal. The other will send several vibrations through the unit that you feel in your chest.
About FDA Recalls for Medical Devices
An FDA recall is a way to remove or correct medical devices that may be in violation of laws that are administered by the agency. A recall is a voluntary action that is done because both distributors and manufacturers are committed to protecting the public health from any products that could cause harm or death.
Medical device recalls such as the above by St. Jude are usually done on a voluntary basis under 21 CFR 7. In some instances, if the device manufacturer will not voluntarily recall the product, FDA can issue a mandatory recall under 21 CFR 810, or Medical Device Recall Authority.
It should be known that a recall is an alternative to a court action initiated by FDA to remove defective products from the market. A recall, however, does not include market withdrawal or a stock recovery.
There are three types of recalls related to medical devices:
- Class 1 – where there is a reasonable chance that using the product could lead to serious health consequences or even death.
- Class 2 – where there is a chance that using the product could cause a temporary adverse event, but the chances of serious health consequences are slim.
- Class 3 – where using the defect product will not likely cause a serious health problem.
When the company recalls the product on its own, that company is asked by FDA to notify their FDA district office. A removal or correction of the product voluntarily by the company is only thought to be a recall if FDA believes the product involves some sort of violation that would be subject to legal action.
FDA asks that the company provide all of the possible information about the product, including the name of the device, total number of the products on the market, the reason for the removal, proposed recall strategy, how many of the products are in distribution channels, and distribution information.
The company may decide in some cases to do a product recall when FDA has decided that the product does violate the law, but FDA did not actually request the recall.
The recalling company should send out a recall letter to affected customers and distributors. The point of the communication is to let people know that the said product has been recalled, and that any use and distribution of the product should stop right away.
A recall will be terminated by the agency when FDA has determined that all efforts that could be made reasonably to remove the product have been done.
Have You Been Hurt by a St. Jude Defibrillator?
A defective St. Jude Medical defibrillator could lead to death or serious injury. If you or a loved one have been hurt by one of the recalled defibrillators – which can include an unnecessary shock to the heart or failure to shock the heart leading to death or injury – you should talk to an experienced defibrillator recall attorney to determine if you have a legal case for compensation.
Complete the form to the right or call us direct right now. We can help.