Medtronic recalls 48 CRM devices on arcing risk

Medtronic (NYSE:MDT) informed physicians last month of a problem with 48 of its cardiac rhythm management devices that’s prompting a Class I recall of the devices. The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were “sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading to the immediate and permanent loss of device functionality,” according to a January doctors letter from quality &regulatory VP Tim Samsel. The issue led to a single instance in which an implanted device failed, in which external defibrillation was required to rescue the patient. The affected CRT-Ds are from Fridley, Minn.-based Medtronic’s Amplia, Claria, Compia and Viva lines. The ICDs involved in the recall are from the Evera and Visia lines. “Due to the nature of this issue, it is not possible to identify which of these 48 devices may fail or when they may fail. Further, we cannot predict how many high-voltage charges can occur prior to a potential failure,” Samsel wrote. Tests on a small number of devices made using the same technique showed that the failure occurred in 23% of devices; 7.7% of the tested devices failed within the first two high-voltage charges, the company said in the letter. The FDA yesterday gave the recall Class I status, denoting the risk of serious injury or death. Patients implanted with the af...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Recalls Regulatory/Compliance Cardiac Rhythm Management Medtronic Source Type: news

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DISCUSSION: A literature review demonstrates no other case series or reports of a primary hyperfunctioning NET of the appendix presenting with hypoglycemic crisis. The symptoms of tumor-induced hypoglycemia more typically arise with islet cell tumors, such as pancreatic NETs or insulinomas. We believe this case represents a nonislet cell tumor-induced hypoglycemia. This patient's elevated serum proinsulin level preoperatively implies secretion of proinsulin by the tumor. However, tumor-induced hypoglycemia caused by proinsulin has been described previously only in pancreatic tumors. This unique case adds knowledge to the p...
Source: The Permanente journal - Category: General Medicine Tags: Perm J Source Type: research
Condition:   Appendicitis Interventions:   Procedure: saline-gentamicin irrigation;   Procedure: saline irrigation Sponsor:   Mansoura University Active, not recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
THURSDAY, April 2, 2020 -- Certain patient and presentation factors increase the likelihood of a missed appendicitis diagnosis in the emergency department, according to a study published online March 9 in JAMA Network Open. Prashant Mahajan, M.D.,...
Source: Drugs.com - Pharma News - Category: Pharmaceuticals Source Type: news
ConclusionsThere was no notable subgroup heterogeneity, which implies that 2-mSv CT can replace CDCT in diverse populations. Further studies are needed for the subgroups for which we had only small data.Key Points• The minute difference in sensitivity or specificity between the 2-mSv CT and conventional-dose CT (typically 7 mSv) groups were consistent across various patient or hospital characteristics.• These results indicate that 2-mSv CT can replace conventional-dose CT in diverse populations.• Further studies are needed to confirm whether 2-mSv CT can replace conventional-dose CT in patients of extre...
Source: European Radiology - Category: Radiology Source Type: research
This article is protected by copyright. All rights reserved.
Source: AIChE Journal - Category: Science Authors: Tags: TRANSPORT PHENOMENA AND FLUID MECHANICS Source Type: research
Journal of Laparoendoscopic&Advanced Surgical Techniques, Ahead of Print.
Source: Journal of Laparoendoscopic and Advanced Surgical Techniques - Category: Surgery Authors: Source Type: research
This article is protected by copyright. All rights reserved.
Source: AIChE Journal - Category: Science Authors: Tags: TRANSPORT PHENOMENA AND FLUID MECHANICS Source Type: research
BOSTON (CBS) – Dr. Paul Biddinger is the Director of Emergency Preparedness at Partners HealthCare. He sat down with WBZ-TV’s Louisa Moller to discuss how the hospital system is coping with COVID-19. Louisa Moller: How are you doing? Dr. Biddinger: “We are doing OK. But I think we still are all aware that we are on the ascending part of the curve and even tougher times are unfortunately probably ahead.” “There have really been extraordinary, extraordinary examples of staff showing up, teaching one another as staff have redeployed to different areas of the hospital.” “People are con...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - Category: Consumer Health News Authors: Tags: Boston News Health Syndicated Local Coronavirus partners healthcare Source Type: news
Dr. Laura Mulvey, 33, practices emergency medicine at Maimonides Medical Center in Brooklyn, New York. After spending six days receiving treatment in her own hospital, she is now recovering at home from what is presumed to be COVID-19, though her test was inconclusive. What follows is a lightly-edited transcript of her story as told to TIME. Early on, sometime in February, [COVID-19] was something that people were thinking about. And worried about. Certainly, the worries were not what they are now. But hospital-wise, we had a bit of an earlier jump on it, because we recognized that this was a potential threat. We’re ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 UnitedWeRise20Disaster Source Type: news
AbstractWidespread dietary exposure of the population of Britain to bovine spongiform encephalopathy (BSE) prions in the 1980s and 1990s led to the emergence of variant Creutzfeldt-Jakob Disease (vCJD) in humans. Two previous appendectomy sample surveys (Appendix-1 and -2) estimated the prevalence of abnormal prion protein (PrP) in the British population exposed to BSE to be 237 per million and 493 per million, respectively. The Appendix-3 survey was recommended to measure the prevalence of abnormal PrP in population groups thought to have been unexposed to BSE. Immunohistochemistry for abnormal PrP was performed on 29,516...
Source: Acta Neuropathologica - Category: Neurology Source Type: research
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