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
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The St. Jude Durata is a newer version of the lead, which has not been recalled or removed from the market.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.
3 Comments • Add Your Comments
susan says:
on 2/20/13 my icd was checked by the St. Judes rep. he showed me the results. he said the lower two leads are fine.the top leadwas very noisey and the results were very different than the rh and lh lower leads (they were large wavy lines but the top atrium lead was showing very, very short little waves. he said to me the bottom two leads are doing fine and they will be enough to cover for the top lead. that it was nothing to be alarmed about. He was not sure what was causing the noise. it might be that it is not attached. He again reassured me not to be alarmed. I was never informed by St. Jude or the New Mexico Heart Institute about a recall.
Posted on March 13, 2013 at 1:42 am
Sylvia says:
Interstim pacemaker placed to my bladder; battery got very hot causing blood in urine; swelling to lower extremities and damage to my kidneys. I need a lawyer to represent me
Posted on September 19, 2013 at 12:53 pm
Don says:
On February 20th 2015 my Saint Jude Medical defibrillator malfunctioned 3 times delivering approx. 800 volts to my heart.
I was driving on the 5 frwy in Irvine ca. On the first shock my head hit the ceiling of my truck. I pulled over and had a friend whose wife called 911 and he kept on the phone with me when it went off a second time. The 3rd time it shocked me is when the ambulance arrived. I asked the paramedics to turn it off they said no. Next stop emergency room and they would not turn it off. Emergency room called saint Jude and a technician told me I’m sorry it malfunctioned and she would not turn it off.
Monday the 23rd I met with my electro physiologist at cedars, he turned it off. I had surgery on Thursday the 26. He added a new wire for the Durata and also right ventricle wire.
Posted on March 9, 2015 at 9:33 pm