St. Jude Durata Lead. The defective medical device lawyers at Parker Waichman LLP are investigating possible fraying defects associated with the St. Jude Durata Lead and battery failures in its Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) devices.
If you or someone you know experienced a malfunction of an internal St. Jude defibrillator that could be associated with a defective Durata Lead Wire or ICD and CRT-D battery, our personal injury attorneys would like to hear from you.
For a free, no obligation St. Jude Durata Lead or ICD or CRT-D battery failure lawsuit evaluation with one of our experienced medical device attorneys, please call 1 800 YOURLAWYER (1-800-968-7529) today.
Premature Battery Failure Reported with St. Jude’s ICD and CRT-D Devices
On October 11, 2016, St. Jude Medical warned physicians about the risk of premature battery failure with its ICD and CRT-D devices. These heart devices are implanted in the upper chest area under the skin.
Insulated wires, known as “leads” connect the ICD or CRT-D to the heart to deliver therapy. Patients suffering from a dangerously slow heart rhythm (bradycardia) need pacing while patients with a fast heart rhythm (tachycardia) need an electrical shock or pacing.
St. Jude warned that some devices manufactured before May 2015 are subject to premature battery depletion. The issue affects the Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, and Unify Quadra models.
According to a safety alert posted on the U.S. Food and Drug Administration (FDA) website, patients and caregivers should respond to the device’s Elective Replacement Indicator (ERI) alerts as soon as possible.
Normally, the battery lasts for an additional three months after the ERI goes off, but St. Jude has received reports of the battery depleting within 24 hours of the ERI alert. The company launched a recall and correction.
Out of 398,740 devices sold worldwide
Out of 398,740 devices sold worldwide, 841 were returned for early battery depletion. If the battery depletes sooner than expected, the ICD and CRT-D may fail to deliver life-saving therapy. As of October 2016, the issue has been linked to two deaths (one in the United States), 10 cases of fainting and 37 reports of dizziness.
The premature battery depletion is caused by the buildup of lithium, known as “lithium clusters, during high voltage charging. Lithium clusters may cause a short circuit that results in premature battery depletion.
Lithium batteries provide charges to the devices’ capacitors. These capacitors deliver the high-voltage shocks needed to bring a patient’s heart to normal rhythms, noted QMed. The chemical reaction leads to the formation of lithium particles that may accumulate in a location that causes a short circuit, which may cause premature battery depletion over the course of anywhere from one day to a few weeks, according to St. Jude..
The design change involved the insulation inside the battery and adding an internal barrier to resolve the risk of a lithium deposit causing a short.
All defibrillators with lithium-chemistry batteries are vulnerable to the formation of an accumulation of lithium outside of the power cell. St. Jude’s engineers found that if the electrically conductive lithium accumulation formed on the batteries in a location on the device that connects its two main components: The anode and cathode.
This may create create a short circuit that quickly depletes the battery. On occasion, the lithium cluster disappears after the short circuit, which makes it challenging to locate the issue.
The ICD or CRT-D device battery may stop working without warning and, in one case, a 61-year-old woman was implanted with a St. Jude Medical heart defibrillator.
The woman, a mother of five, learned that, although St. Jude corrected the issue
The woman, a mother of five, learned that, although St. Jude corrected the issue in 2015 that led the recall, St. Jude also continued selling the older units. She was implanted with one of the older units, according to a November 2016 The Star Tribune report.
Meanwhile, the two confirmed cases of patient deaths were made when the battery issue caused their St. Jude devices failed to administer life-saving shocks. One death occurred in 2014 and another in earlier 2016. While St. Jude indicates that the failure rate is very low, the FDA indicates that the incidence rate remains unknown, according to The Star Tribune.
In November 2016 interviews. St. Jude executives indicated that they moved rapidly when the discovered the issue, immediately advised physicians globally regarding the recall decisions, and has continued to review the matter since the problem was first published in 2014.
Yet, St. Jude also admits that its shipment of old devices continued for 17 months after upgrading the device’s design to stop the unexpected power loss, according to The Star Tribune.
Meanwhile, it remains unclear when St. Jude began selling cardiac devices with the new batteries and if there was a time frame in which both versions were sold simultaneously and with no disclosure of the difference. Devices impacted by the defect and recall include the following St. Jude devices:
- St. Jude’s Fortify VR
- St. Jude’s Fortify ST VR
- St. Jude’s Fortify Assura VR
- St. Jude’s Fortify Assura ST VR
- St. Jude’s Fortify DR
- St. Jude’s Fortify ST DR
- St. Jude’s Fortify Assura DR
- St. Jude’s Fortify Assura ST DR
- St. Jude’s Unify
- St. Jude’s Unify Quadra
- St. Jude’s Unify Assura
- St. Jude’s Quadra Assura
- St. Jude’s Quadra Assura MP
St. Jude executives said that the battery design was changed on May 23, 2015 in response to the issue discovered in 2014; however, they also indicated they were unaware if the problem would become so widespread as to impact 350,000 devices implanted in patients worldwide, Chief Medical Officer Dr. Mark Carlson said, according to The Star Tribune. Of the total 349,852 affected devices, approximately 199,642 involve U.S. patients, according to FDA, wrote QMed.
We have a device that, at that time, is performing well, and we are making it even better
“We have a device that, at that time, is performing well, and we are making it even better,” Dr. Carlson said in November 2016, describing the decision in May 2015 against advising the public about the change in design.
According to The Star Tribune, the design change received regulator approval, which included approval by the FDA. FDA spokeswoman Angela Stark wrote in an email that the federal regulator did not mandate St. Jude to recall the old devices after the design change because data at the time found that the rate of issues was low.
Data revealed since has revealed that the risk was higher than first believed, according to Ms. Stark. “St. Jude is no longer selling the affected devices, and has instructed health care providers not to implant any unused affected devices and to send them back” to the manufacturer, Stark wrote. Neither St. Jude nor the FDA yet knows how many unused devices will be returned.
Physicians complain that the timing of the St. Jude recall is concerning because they only learned about the ICD battery issue at around the same time the public was made aware.
This means that doctors were implanting patients with the devices constructed with the older, defective batteries, including patients whose ongoing health was contingent upon their defibrillators working as pacemakers to improve their heart’s oxygenated blood output, noted The Star Tribune.
“I’m very angry because those patients put their lives in my hands,” said Dr. Kevin Campbell, a North Carolina cardiac electrophysiologist who told The Star Tribune that he unknowingly implanted the older devices in patients after St. Jude created the improved design.
“If it’s a big-enough deal to change the manufacturing process, then pull it off the shelf,” he added. Dr. Campbell also said the Heart Rhythm Society is creating medical guidelines on defibrillator treatment in patients whose devices have the old batteries.
Both the FDA and St. Jude recommend that St. Jude patients whose defibrillators have older batteries be placed on home monitoring. This will enable reading of the device’s battery level when the patient is in range of a monitoring device.
All patients implanted with the affected St. Jude devices must seek immediate care if they feel the vibratory alarm in their chest, which may mean that the battery may short out and completely deplete in under 24 hours.
St. Jude Durata Lead Wire Fraying Injury Reports
St. Jude Medical Inc.’s Durata Lead Wire, which is used to connect an internal defibrillator to the heart, is raising concerns following a report that a Durata Lead frayed in at least one patient.
The fraying of the St. Jude Durata Lead resulted in the wire becoming exposed through its insulation. If other Durata Leads suffer from a similar fraying defect, there is a risk that exposed wires could cause an implantable defibrillator to emit shocks at inappropriate times, or fail to do so when necessary.
Either scenario could result in serious injury to, or death of, patients who have had Durata Leads implanted along with an internal defibrillator.
The Durata Lead Wire was introduced by St. Jude as a replacement for its controversial Riata Leads. St. Jude stopped selling Riata Leads in December 2010, and recalled them one year later, after the company received reports of the wires penetrating the device’s insulation.
When the Riata Leads were officially recalled in December 2011, at least two patient deaths had been attributed to the defect. The Durata Lead was made with a new type of insulation coating, called Optim, which was supposed to prevent fraying.
In June 2012, a physician reported to the FDA that a Durata Lead Wire had frayed in a patient. “Non invasive programmed stimulation of ICD, revealed under sensing of ventricular fibrillation after induction,” the report indicated.
“Fluoroscopy of lead revealed externalization of conductors. The externalization was confirmed at lead extraction. The externalization was adjacent to the distal coil of the lead.” According to the report, the incident occurred on April 18, 2012. No other details were given.
The report sparked concern that the Durata Lead Wire could suffer from the same problems that resulted in the Riata Lead recall. The report also raised questions about the use of St. Jude’s smaller diameter leads should be used when other more reliable leads are available.
Need Legal Help Regarding St. Jude Durata Lead?
If you or someone you know sustained an injury that could be related to a frayed St. Jude Durata Lead Wire or defective batteries in St. Jude ICD and CRT-D devices, you may have valuable legal rights. For a free, no obligation lawsuit evaluation with one of the experienced medical device lawyers at Parker Waichman LLP, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529).