Devices

FDA Says Medtronic Pump Recall is Class 1

FDA says that the Medtronic 9/2016 recall of its SynchroMed implantable infusion pumps due to a software problem that may cause unintended delivery of drugs during a priming bolus procedure is Class 1. An agency notice says the SynchroMed II and SynchroMed EL implantable infusion pumps are programmed to deliver prescribed drugs to a specific site inside a patient’s body. The pumps are used to treat primary or metastatic cancer, chronic pain, and severe spasticity, it says.

During a priming bolus procedure used to quickly deliver a large dose of medication from the device to the patient’s spine, FDA says, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus. The agency says this can result in a drug overdose or under-dose, which can lead to serious adverse health consequences, such as respiratory depression, coma, or death.

The notice says that Medtronic sent an urgent medical device correction notice to affected customers 9/2016 with a description of the software change, description of labeling changes, software card recommendations, and new priming bolus recommendations. Company representatives began visiting affected customers 10/3/16 to install updated software application cards.

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