Automated systems that comb through hospital databases of information on devices like implanted defibrillators and pacemakers find safety problems years before current approaches identify deadly defects, researchers said.
Investigators compiled information on 2,710 patients who had defibrillators connected to the heart with Medtronic Inc. (MDT)’s Sprint Fidelis lead or the company’s Quattro Secure leads between November 2001 and December 2008. Minneapolis-based Medtronic halted sales of Sprint Fidelis in 2007 because of the device’s potential to fracture and its ties to several deaths.
The automated safety review program from closely held Coping Systems Inc. in Cambridge, Massachusetts, would have triggered an alert for Fidelis just 13 months after the first lead was implanted and two years before it was pulled from the market, the study found.
“If the American public and patients knew how little their doctors and the FDA knew about the performance of these devices, they would be shocked,” said lead researcher Robert Hauser, a cardiologist at the Minneapolis Heart Institute. “The companies should use this software because it turns up problems early and it’s good for their business, not to mention patients.”
The current safety system relies on doctors and companies to spot malfunctions and report them to the U.S. Food and Drug Administration. Delays in reporting to the FDA can hold up findings on device flaws.
New Study Planned
Hauser plans to start a study in June on St. Jude Medical Inc. (STJ)’s Durata lead, he said in a telephone interview. The St. Paul, Minnesota-based company stopped selling an older lead known as Riata in December 2010 and recalled it a year later because it can break through the insulated coating. There are no reports of similar problems with the Durata lead, and Hauser said the surveillance could continue for years.
Medtronic has seen the study and finds the results interesting, said Christopher Garland, a company spokesman, in an email.
“Device safety and reliability are top priorities for Medtronic, so anything that can further those priorities is of interest,” he said.
Amy Jo Meyer, a spokeswoman for St. Jude, declined to comment on the study.
The research, published in the journal Circulation: Cardiovascular Quality and Outcomes, was funded by the Minneapolis Heart Institute Foundation and Abbott Northwestern Hospital Foundation. The researchers used databases from the Minneapolis Heart Institute, the Mayo Clinic in Rochester, Minnesota, and Beth Israel Deaconess Medical Center in Boston.
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