MINNEAPOLIS (AP) — Medtronic Inc. is stopping distribution of wires that connect some of its defibrillators to patients' hearts after learning they may have contributed to five deaths.
Medtronic shares dropped nearly 13 percent by late morning Monday after the disclosure.
A defibrillator monitors a patient's heartbeat; if it senses an abnormal heart rhythm, it delivers an electronic shock to reset the heart to a normal beat. A defibrillation system consists of a device implanted near the shoulder with one or more leads connecting the device to the heart.
Medtronic said it discovered a ''small chance of fractures in particular locations'' on Sprint Fidelis models 6930, 6931, 6948 and 6949. The company is asking doctors to stop implanting the leads and return all unused leads to Medtronic.
A fractured lead ''can cause the defibrillator to deliver unnecessary shocks or not operate at all,'' said Daniel Schultz, director of the Food and Drug Administration's Center for Devices and Radiological Health.
The company is not recommending that patients with such a lead have it removed, since they ''are more likely to experience complications from removal.'' Instead, Medtronic said, doctors can reprogram the device to alert the patient that a fracture may have occurred. Possible indicators could include audible alerts or inappropriate shocks.
''We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect,'' Schultz said. ''However, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized.''
More than 268,000 of the leads have been implanted. Medtronic and the FDA estimated that fractures have occurred in less than 1 percent of those leads.
In a filing with the Securities and Exchange Commission, Medtronic Chief Financial Officer Gary L. Ellis said the recall will likely cause ''significant repercussions'' to the Japanese market because the company currently has no other leads approved in this market.
In addition, the company will have to account for product returns of its Fidelis lead, which won't be able to be replaced with an alternative until later this year due to a shortage of Sprint Quattro supplies. This will cause a ''significant revenue reversal'' in the company's fiscal second quarter.
The product recalls also mean customer bulk purchase orders will either have to be adjusted or in many cases may not be able to be filled due to the limited Sprint Quattro supply.
Medtronic said the recall-related issues will reduce second-quarter revenue by $150 million to $250 million. Additionally, inventory write-offs will likely total about $15 million to $20 million in the second quarter, and Medtronic sees other direct costs related to the recall of $10 million to $20 million.
Medtronic senior vice president Pat Mackin emphasized that the company's action does not apply to Medtronic pacemakers.
Its shares fell $7.13, or 12.6 percent, to $49.20 in morning trading Monday.
Medtronic advises patients with Sprint Fidelis leads to contact their doctor's office. Patients who are unsure about whether they have a Sprint Fidelis lead can contact Medtronic Patient Services at 1-800-551-5544, extension 41835, or visit http://www.medtronic.com/fidelis.
