Medical Device Daily Associate

St. Jude Medical (St. Paul, Minnesota) reported that it has notified physicians that certain of its implantable cardioverter defibrillators (ICDs) are in need of a non-invasive, 45-second software upgrade to correct two anomalies found during “routine product evaluation.”

The company said the anomalies do not pose a “significant risk” to patients and that so far, it has not received any reports of patient adverse events or clinical complications as a result of the anomalies.

In addition to notifying its customers, St. Jude said it is providing physicians with a simple software tool to correct the issues via its programmer.

A programmer is a special tabletop computer that enables a physician to communicate non-invasively with a patient’s implanted device. A telemetry wand is placed on the patient’s chest and the programmer will automatically detect the affected ICDs and download the new software to the device.

The company, in consultation with a group of consulting physicians, has recommended that this be done at the patient’s next routine follow-up visit or at the physician’s discretion.

The notification comes in the wake of rival Guidant’s (Indianapolis) recent recall of nearly 50,000 ICDs that was coupled with an alleged failure to alert physicians and patients to the danger of one of the devices mentioned in that recall until nearly three years after it was aware of the problem (Medical Device Daily, June 21, 2005).

The company said it has “worked actively” with the FDA in approving the software upgrade and in developing an implementation plan, in consultation with a physician advisory panel, to proactively issue the voluntary notification. The software upgrade was approved by the FDA on June 17, and has already been sent to physician customers.

According to Angela Craig, vice president of corporate communications, the timing of the company's announcement in relation to Guidant's recent problems is coincidental. "We've been engaged with the FDA on the software upgrade long before the media coverage surrounding our competitor," she told Medical Device Daily.

St. Jude said it recently discovered during examination of a single returned device that it could be possible when a device’s battery voltage is past mid-life and approaching its elective replacement indicator (ERI), for a charging cycle to be skipped as the device attempts to deliver multiple shocks in rapid succession.

If this were to occur, the first shock would always be delivered by the device as programmed. A subsequent shock in the sequence could be delivered after a two- to four-second delay, but the anomaly could cause the device to have fewer than the maximum total of six therapeutic shocks available for a single diagnosed episode as called for in the product’s labeling. There have been no reports of any patient adverse events or clinical complications at this time, the company said.

The second anomaly in some devices is an electrical “noise” generated as a result of the charging of the device’s high-voltage capacitors (tracked back to a component supplied by one vendor).

The noise in the capacitor can be interpreted by the device’s sensors as activity if programmed on, causing a temporary increase in the pacing rate. Again, St. Jude said each of the devices has a safe maximum pacing rate set by the patient’s physician, and the company said it has not received any reports of patient adverse events or clinical complications.

“As a member of St. Jude Medical’s advisory group reviewing these issues, I am confident that the company has taken the appropriate proactive steps in resolving the anomalies in the best interest of patients,” said Bruce Wilkoff, MD, director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic Heart Center (Cleveland). There are about 39,000 Epic and Atlas devices implanted worldwide that are subject to one or the other software upgrade, according to St. Jude.

St. Jude Medical said it does not expect this advisory to have any material financial impact.

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