Monday a medical journal published findings suggesting that St. Jude’s defibrillator leads may puncture the heart on rare occasions. Four cases were highlighted Monday’s PACE Journal publication. The cases in question involve St. Jude’s Riata leads; two cases were reported in the Czech Republic and two more in the United States. A 71-year-old New York woman’s Riata lead came within a quarter of an inch of perforating her skin.
The FDA database for medical device-related injuries and deaths notes 15 incidents involving a perforation with a Riata lead and one death, according to Vlay’s research
But Vlay believes that the number of incidents involving Riata leads perforating the heart may be underreported by doctors and health care professionals. He urged his peers to come forward if they encounter such an incident.
St. Jude claims that their leads are safe and neither the company nor the FDA has issued a recall of the medical devices. There has been an increased focus on defibrillator lead safety after Medtronic Inc.’s Sprint Fidelis Leads were linked to five deaths. The FDA and Medtronic issued a Class I recall of these leads due to risk of fracture.
For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.