Heart perforations from St. Jude Medical Inc. wires known
A medical device similar to the Medtronic implantable defibrillators has reportedly been implicated in a number of cases of perforated hearts. The medical journal PACE reported that wires from the St. Jude Medical Inc. implantable defibrillators are known to have perforated four patient’s hearts. According to the journal, one patient had a wire move from inside the heart out to a quarter inch from the patient’s skin. Regardless of the difficulties experienced by these heart patients, the company has issued no recall. Last month, Medtronic Inc. acknowledged five patient deaths linked to breaks in its Sprint Fidelis wires, which have since been recalled. All four of the patients with the St. Jude wires had them 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 after her defibrillator had been implanted. The defibrillator had not been delivering a sufficient jolt. Doctor's found the perforation in another woman after her defibrillator shocked her five times within one 24-hour period. Vlay believes that doctors may not have been reporting the wire problems because they thought they were isolated events. “It was only when multiple case reports emerged from different geographic areas and were submitted for publication that editors recognized a problem that seemed to be neither isolated nor rare,” he wrote.
