St. Jude devices have wire problems
MINNEAPOLIS - Wires from St. Jude Medical implantable defibrillators have perforated patients' hearts in four cases, a medical journal reported yesterday, less than a month after rival Medtronic recalled its own similar wires.
One patient's wire had moved from inside the heart out to within a quarter inch of the patient's skin, according to the reports published by the medical journal PACE.
All four of the patients with St. Jude wires recovered, and the company issued no recall. Still, St. Jude Medical Inc. shares dropped almost 5 percent on the news.
Last month, Medtronic Inc. acknowledged five patient deaths linked breaks in its Sprint Fidelis wires, which it recalled.
Implantable defibrillators are meant to jolt the heart back to its proper rhythm. The wires, called leads, are attached to the heart wall and deliver the jolt. A failure of the lead can mean the defibrillator never senses the need for the jolt, or can't deliver it.
The journal PACE reported four women with perforations from St. Jude's Riata leads. The patients - one treated in Nebraska, one in New York, and two in the Czech Republic - all had their leads removed.
Dr. Stephen C. Vlay wrote in a PACE editorial that the wire problems are especially troubling because the perforation often isn't discovered until it is well through the heart wall.
One woman had no sign of problems. Doctors discovered her perforation in a routine follow-up visit about five weeks after her defibrillator was implanted. The defibrillator had not been delivering a sufficient jolt, the journal said.
Vlay wrote that doctors may have been under-reporting wire problems because they believed they were isolated events. 