St. Jude Defibrillator Lead Problems
As a result of serious and potentially life-threatening St. Jude defibrillator lead problems, the FDA is calling on doctors to conduct additional imaging scans on certain patients and requiring new studies to assess the safety of the following products:
- St. Jude Riata and Riata ST ICD and CRT-D Leads
- St. Jude QuickFlex LV CRT Leads
- St. Jude QuickSite LV CRT Leads
- St. Jude Riata ST Optim ICD Leads
- St. Jude Durata ICD Leads
Have You or A Loved One Had Problems With A St. Jude Lead?
These leads contain small wires that are used to connect an implantable defibrillator to the heart, and monitor for abnormal heart rhythms. They are used with either an implantable cardioverter defibrilator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
As a result of design and manufacturing defects, a St. Jude defibrillator lead recall was issued last year for the Riata and Riata ST leads.
The recall came after St. Jude stopped selling the leads in 2010 and issued warnings about reports that the small wires were poking through the insulation. This could cause individuals to experience unnecessary shocks or cause their defibrillator to fail when it is needed to deliver a life-saving charge.
According to new FDA guidelines released this week, the agency has recommended that doctors conduct either chest x-rays or fluoroscopy exams on patients who have a recalled St. Jude Riata lead to determine whether the insulation has failed and whether the lead is still function properly. The agency has also called on doctors to consider remote monitoring of patients, so that they can quickly determine if there is any abnormal electrical activity from the leads.
Although these recommendations currently only apply to the recalled Riata and Riata ST leads, the FDA has ordered St. Jude Medical to conduct additional surveillance studies on other leads that feature similar designs, including the QuickFlex, QuickSite and Durata leads.
These trials will involve a three year study to look for premature insulation failure and other possible problems with the St. Jude defibrillator leads.
In April 2012, St Jude indicated that they will stop selling the QuickSite and QuickFlex left-ventricular leads, which are used in CRT-D devices. The manufacturer indicated at that time that the leads may have insulation problems, after at least 39 reports were identified where the conductors poked through the insulation.
The St. Jude Durata is a newer version of the lead, which has not been recalled or removed from the market. Although the manufacturer has suggested there is no evidence of similar problems, at least one adverse event report submitted to the FDA’s MAUDE database has indicated that a Durata lead had to be removed because the conductors were poking through the insulation.
ST. JUDE DEFIBRILLATOR LEAD LAWSUIT LAWYERS
The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential St. Jude defibrillator lead lawsuits for individuals who experienced problems after receiving one of these recalled leads. We are also closely monitoring the FDA ordered studies on the other St. Jude lead wires, which may also prove to experience similar problems.
To review a potential claim for St. Jude Defibrillator lead problems experienced by yourself, a friend or family member, request a free consultation and claim evaluation.