LOS ANGELES, March 13 (Reuters) - Medtronic Inc MDT.N said the number of deaths in which fractured defibrillator wires may have been a "possible or likely contributing factor" have risen to 13, the Wall Street Journal reported on Friday.
The wires, called “leads,” went by the brand name Sprint Fidelis until they were pulled from the world market in October 2007. The leads are designed to carry electrical jolts to the heart and correct erratic heartbeats.
The newspaper said the new numbers, contained in a letter to doctors, were the company’s first update of its death estimate since the Sprint Fidelis -- once the No. 1 such device in the world -- was recalled.
At that time, Minneapolis-based Medtronic said its device could have contributed to five deaths. An estimated 268,000 Sprint Fidelis leads were implanted in patients worldwide. When the leads fracture, the company and doctors say they can either fail to dispatch the needed electrical therapy, or can fire off multiple unnecessary shocks that can result in death.
The Journal said four of the 13 deaths resulted from attempts by doctors to pull out Sprint Fidelis leads -- highlighting the risk of extraction surgery. The leads typically scar onto the inner vein wall leading to the heart, or can scar onto the heart itself. Either way, pulling them out can result in lethal bleeding. For that reason, the company still does not recommend extraction in most cases.
The newspaper reported Medtronic had received 107 reports “that include allegations that the Fidelis lead may have caused or contributed to a patient death.” (Reporting by Deena Beasley; Editing by Andre Grenon)
Our Standards: The Thomson Reuters Trust Principles.