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Group says FDA should have called for earlier Medtronic lead recall |
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Tuesday, 16 October 2007 |
A leading consumer advocacy group says that rising injury reports should have led the Food and Drug Administration to issue a Medtronic lead recall earlier this year. The Sprint Fidelis leads were only recalled by Medtronic on October 14 after the company learned of at least five deaths that may have been caused by malfunctions with the lead wires.
According to Public Citizen, the FDA had received at least 599 reports of malfunctions or injuries among patients wearing a defibrillator with one of the Sprint Fidelis leads as of January 10. At least 204 of these patients suffered painful, unnecessary shocks to the heart due to fractures in the lead wires. Dr. Sidney Wolfe, the head of Public Citizen, says that the FDA had received at least 1,030 additional reports of defibrillator wire problems for the Sprint Fidelis leads since January.
Medtronic recalled the Sprint Fidelis wires because they were more likely to fracture than other lead wires manufactured by the company. Medtronic says that about one in 43 patients will experience a malfunction in their Sprint Fidelis leads, more than twice the rate with other lead wires.
Public Citizen says that the high number of defibrillator wire problems, combined with a rising number of reports in 2007, should have prompted the FDA to force Medtronic to issue a defibrillator recall for the Sprint Fidelis leads. The group says that the FDA received 152 reported of malfunction in the first two months of 2007, compared with only 27 during the same period in 2006. |