Devices

Alert on Medtronic Pacemakers Due to Battery Drainage

FDA has issued a safety alert on certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) about issues that may cause their batteries in to drain more quickly than expected without warning patients or health care providers. The agency says it has received three medical device reports in which an affected Medtronic device had fully drained without warning because of a crack in the device’s capacitor.

“If a capacitor in an implanted pacemaker or CRT-P is cracked, it can create an electric short, which can cause a battery to drain earlier than expected,” the alert says. “If the battery is completely drained, the device will no longer deliver pacing therapy. The patients who rely heavily on pacing or who are pacemaker dependent may be most at risk for having an adverse outcome.” Medtronic reported that the events occurred within one year after the patient was implanted with the device, on average within seven months of having it implanted.

The alert recommends against removal and replacement of affected devices. Instead, patients and health professionals should monitor battery status using home monitoring systems. “Due to the low frequency of device failure, the FDA believes these are appropriate mitigations for most patients, as patients could be at greater risk of complications from the surgical procedure required to replace the device,” it says. Additionally, Medtronic recently received FDA approval to add a new step in its manufacturing process to better detect capacitor failures in newly manufactured devices, and to use a different capacitor.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome