Devices

Medtronic Alternative Summary Reporting for Defibrillator Examined

For a decade, Medtronic was allowed by FDA to report thousands of adverse events associated with the company’s Sprint Fidelis defibrillator under a publicly-shielded “alternative summary reporting” program, according to a Kaiser Health News (KHN) report posted on CNN.com. Faced with criticism, FDA has ceased the alternative summary program that allowed the reporting exemption, FDA spokeswoman Deborah Kotz told KHN. She said FDA hasn't granted such an exemption since 2015 and has “effectively ended the program,” and could not say whether the older data would be opened to the public soon.

Medtronic said in the report that it logged more than 50,000 instances of harm or malfunction, with more than one problem reported for some of the 35,000 cases. Medtronic also says that its Independent Physician Quality Panel has been reviewing data on the device since 2007 and that the information has been periodically reported to physicians. "Patient safety is our top priority," company spokesman Jeffrey Trauring is quoted in the report as saying.

FDA’s Kotz said that FDA has "worked closely with Medtronic" to monitor the performance of the recalled leads and “ensure appropriate patient management recommendations are available to clinicians” in twice-yearly performance reports. “[Medtronic provides] additional information on product performance and safety in a more comprehensive format than what we receive in summary reports,” she said. None of Medtronic’s publications, though, offer details about the 50,000 malfunction and harm reports the company sent to the agency over 10 years. Those reports define the number of lead fractures or instances of inappropriate shocks.

The KHN report noted that death cases were not filed with alternative report summaries. “Since the 2007 recall, more than 2,300 reports of deaths in which the device was suspected to have played a role were filed with the FDA and are publicly available, records filed in MAUDE show,” according to the report.

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