St. Jude Cautions Physicians About Defective Pacemakers
WESTPORT, Feb 17 (Reuters Health) - St. Jude Medical, the St. Paul, Minnesota-based manufacturer of cardiac devices, sent a letter to physicians this week informing them that some of its Affinity pulse generators, models 5330 and 5130 in the US and models 5330, 5130, and 5230 outside the US and Canada, might be defective.
According to the letter dated February 14, St. Jude said that "conductive material used to secure a resistor to the device circuitry may not provide continuous and proper electrical connection in this small population of devices."
The company explained that the defect could cause the device to exhibit abnormal measured battery data, a false recommended replacement indication, reversion to backup mode, or output anomalies, including intermittent loss of output. It said that, to date, 33 devices had exhibited one or more of these anomalies.
St. Jude said that the potential problem is limited to 891 devices that it shipped in June. It noted that the potential problem does not affect other Affinity family devices. The company believes that the problem will affect approximately 10% of the devices over a 5-year period, with more than half of those occurring within the first year of shipping.
The company suggests that physicians should decide on a case-by-case basis whether to replace the implanted pulse generator as a preventive measure. It said, "St. Jude Medical will provide a replacement Affinity pulse generator at no charge. In addition, up to $800 of the patient's unreimbursed medical expenses will be provided upon receipt of the expense statements, with a check sent to the patient."
Along with the letter, St. Jude provided physicians with the names of patients they treat who have the affected devices implanted.
The advisory letter comes just 3 weeks after St. Jude initiated a worldwide recall of its heart valve replacement and repair products that incorporate the company's Silzone coating on the sewing cuff fabric. As Reuters Health reported on January 25, the company initiated a recall after several devices with the coating had to be explanted due to paravalvular leaks.
In an effort to quell concerns that the recent problems reflect a lack of quality assurance or product reliability, St. Jude noted that its Pacesetter and Ventritex products have been the subject of 14 actions (such as safety alerts or recalls) in the past 15 years compared with 28 such actions for market leader Medtronic.
In late Wednesday afternoon trade, shares in St. Jude fell 15/16 to 26-1/2 on the New York Stock Exchange.
cardiology.medscape.com
Certainly not good news for St. Jude.
Jack |
