Legal Updates
Synchromed & MiniMed Pumps Made by Medtronic Get FDA Warning
Wednesday, June 24, 2009
On June 24, 2009, the FDA warned Medtronic Inc. about failing to properly report and handle problems with its Synchromed drug-infusion pump and its MiniMed insulin pump. In a June 1, 2009 warning letter, the FDA said it took Medtronic two years to recall its Synchomed II Pumps after discovering…
Medical Company Accused of Improper Use of Bone Cement
Wednesday, June 17, 2009
On June 16, 2009, prosecutors in Philadelphia, Pennsylvania charged a local medical-device company with illegally testing bone cement during spinal surgeries on nearly 200 patients, in which three died on the operating table. The lengthy indictment charges that West Chester-based Norian Corp. trained dozens of surgeons to conduct unofficial clinical…
Medtronic Pacemakers Recalled
Thursday, June 11, 2009
On June 11, 2009, the FDA alerted patients of a Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Patients with faulty pacemakers may experience a…
Doctor Brings to Attention Problems With Zimmer Durom Cup Hip Replacement Devices
Monday, June 08, 2009
A story about a local doctor and his patient’s problems brought about by the Zimmer Durom cup medical device can be found in a June 8, 2009 article in the Fort Wayne Journal Gazette .When Dr. Lawrence Dorr noticed patients had problems with the Durom cup, a hip-socket implant, loosening…
Medtronic Warns of Faulty Pacemakers
Thursday, May 21, 2009
On May 18, 2009, Medtronic Inc. sent doctors a letter informing them about potential issues with wires in some older pacemakers that affect nearly 37,000 devices and may lead doctors to remove and replace some of them. The issues covered in the "Dear Doctor" letter involve a small fraction of…
Infant Sleep Apnea Monitors Recalled
Monday, May 18, 2009
On May 18, 2009, Respironics, a Philips Healthcare company announced a voluntarily recall of approximately 4,992 infant apnea monitors. The recall is for the SmartMonitor2 models 4002 and 4003. There is a possibility of audible alarm failure in the monitors. According to Respironics, the SmartMonitor 2 infant apnea monitor is…
