WASHINGTON (Reuters) - Patient injury reports for the tiny wires used with Medtronic’s implantable heart devices jumped dramatically in the past year, a consumer group said on Tuesday, a day after the wires were recalled for possible links to five deaths.
U.S. health regulators received reports of 1,194 patient injuries in the first 10 months of 2007, compared with 296 in the same period in 2006, the consumer group Public Citizen said, citing U.S. Food and Drug Administration data.
The jump in numbers of patient injuries, and an even greater increase in reports of inappropriate patient shock, was apparent in the first few months of 2007, the group said.
On Monday, Medtronic halted sales of the Sprint Fidelis line of “leads,” the wires that link the heart to an implantable cardioverter defibrillator, or ICD, a life-saving device that can shock a racing heartbeat back to normal rhythm.
The company cited as reason for the suspension five patient deaths where fracture of the tiny wires “may have been a possible or likely contributing factor.”
The FDA said on Monday the risk of lead fractures is small, less than 1 percent of those implanted.
An FDA official said that the rising number of reports did not appear problematic because the product seemed similar to others like it, made by Medtronic, in terms of overall patient survival.
“It is hard to know, just because you have a large number of reports, how to interpret them,” Megan Moynahan, chief of the FDA’s pacing branch, said in an interview on Tuesday. “It’s only one piece of the picture.”
Reports to the FDA are widely viewed as representing only a fraction of actual problems with drugs and medical devices.
“One of the things we do is rely on the company,” Moynahan said.
Public Citizen said if the FDA had acted earlier, patients could have been spared injuries and anxiety.
“Why did the FDA, aware of the rapidly mounting number of injury reports, not force the company to recall defibrillators not yet implanted in the early part of the year?” Public Citizen health research director Sidney Wolfe wrote in a letter sent to FDA Commissioner Andrew Von Eschenbach on Tuesday.
Medtronic spokesman Rob Clark on Tuesday said that ICDs are implanted to prevent sudden cardiac arrest, which kills about 1,000 people a day in the U.S. Medtronic said the benefits far outweigh the risks from the devices. He also noted the company first contacted doctors about the issue in March.
The Minneapolis-based company controls about half of the $6 billion global market for ICDs. About 268,000 leads have been implanted worldwide, according to Medtronic.