Canadians are suing Medtronic over faulty Sprint Fidelis defribllator leads. The faulty leads were globally recalled by Medtronic in 2007.
Lead wires are placed into a major vein and attached to interior heart muscle for the purpose of monitoring heart rhythm and transmitting electric shocks should an irregularity occur. If a lead breaks, the implantable cardiac defibrillator (ICD) can emit a massive and painful shock. In the worse case, the fractured lead can prevent an ICD from sending a necessary, lifesaving shock to the heart.
As we’ve written, Medtronic Inc. recalled its Sprint Fidelis defibrillator lead, approved in the U.S. under the 510(k) process, after it was found to have a higher-than-normal fracture rate and was implicated in five deaths. Sadly, the U.S. Food and Drug Administration (FDA) only mandates thorough testing for less than one-tenth of all devices, and continues to defend the 510(k) approval process, which the agency claims promotes innovation.
According to a prior Bloomberg.com report, the FDA has given expedited reviews to nearly 70 devices since January 2009, when the Government Accountability Office (GAO) called for immediate steps to strengthen standards or reclassify risks. As we’ve explained, the FDA’s policy of fast-tracking medical devices contrasts greatly with its process for drug approvals in which new medications must be studied in thousands of people to determine safety and efficacy prior to approval for market release. By contrast, medical device makers must simply demonstrate a device does what they claim, and that it poses no undue safety risks. Unlike a new drug, a device approved under 510(k) does not have to prove efficacy.
Since the recall, about 20 more fatalities have been linked to the devices said CBC News, adding that studies revealed that the devices’ failure rate increase over time.
“These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all,” Medtronic said in a release, wrote CBC News. “Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.” The action involved Sprint Fidelis models 6930, 6931, 6948 and 6949.
At least one cardiac surgeon said that doctors at the hospital where he works—St. Paul’s Hospital in Vancouver—have removed upwards of about 100 leads from patients. “We had seen ourselves at St. Paul’s some failures of the lead,” said Dr. Jamil Bashir,” wrote CBC News. “We had been concerned about that and we mentioned it to the company. It wasn’t too far after that the recall actually happened.”
Replacing a lead is dangerous and the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture; a choice with which many patients are uncomfortable.
Sherry Robinson of Sechelt, British Columbia, told CBC News that she suffered a number of violent shocks to her heart before her leads were removed. Since, Robinson has joined a class action lawsuit that includes over 6,300 Canadians.
One plaintiff attorney said Medtronic’s actions went beyond negligence; the lawsuit alleges Medtronic did not disclose the device’s defects in a timely manner, said CBC News. Plaintiff attorneys also allege that the fast-tracked approval was based on prior, more reliable leads, which were made thinner by Medtronic. Dr. Bashir noted that a clinical trial should have been conducted before patients were implanted with the revised device, said CBC News.