MedSun: HeartNet
HeartNet
These subnetworks are designed to collect and share information about actual and potential adverse events from specific clinical areas of MedSun facilities using high-risk products.
For related information, see the latest device approvals that may be relevant to your specific clinical area.
The following is the latest content from the HeartNet Subnetwork:
HeartNet
Focuses on identifying, understanding, and solving problems with medical devices used in electrophysiology laboratories. To see recently submitted MedSun Cardiovascular and EP Device Reports, see Cardiovascular including EP Devices.
Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers |
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FDA Recall Notice
Medtronic and FDA notified healthcare professionals and patients of a Class I recall of Medtronic Kappa Series 600/700/900 and Sigma Series 100/200/300 pacemakers due to a failure of the devices to pace the heart. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.
Additional Information:
Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers. FDA Recall Notice. May 18, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm166344.htm
FDA Alerts Patients to Medtronic Pacemaker Recall. FDA Press Release. June 11, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165853.htm
Patients Alerted to Pacemaker Recall. FDA Consumer Information. June 11, 2009.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm165619.htm
All HeartNet Content to Date
- (July 2009) Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers
- (December 2008) Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System
- (November 2008) Review of the Registry's Second Year, Data Collected, and Plans to Add Lead and Pediatric ICD Procedures
- (October 2008) FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures
- (October 2008) New Device Approval - Medtronic® Attain Starfix Model 4195 Lead - P060039
- (October 2008) Recently Recalled Devices
- (September 2008) Implantable Cardiac Defibrillator Lead Failure or Mypotential Oversensing? An Approach to the Diagnosis of Noise on Lead Electrogram
- (September 2008) Hypersensitivity Reactions Associated with Endovascular Devices
- (September 2008) Recently Recalled Devices
- (August 2008) ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary
- (August 2008) Problems with Implantable Cardiac Device Therapy
- (August 2008) Recently Recalled Devices
- (July 2008) Lead-Associated Endocarditis: the Important Role of Methicillin-Resistant Staphylococcus Aureus
- (July 2008) ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines
- (July 2008) Pacemaker and ICD leads: Strategies for Long-Term Management
- (July 2008) Recently Recalled Devices
- (June 2008) Large, Single-Center, Single-Operator Experience with Transvenous Lead Extraction: Outcomes and Changing Indications
- (June 2008) Design of the Pacemaker Remote Follow-up Evaluation and Review (PREFER) Trial to Assess the Clinical Value of the Remote Pacemaker Interrogation in the Management of Pacemaker Patients
- (June 2008) Complexity of MRI Induced Heating on Metallic Leads: Experimental Measurements of 374 Configurations
- (June 2008) Recently Recalled Devices
- (May 2008) Of Special Interest to Electrophysiology and Cath Lab Staff/HeartNet
- (April 2008) Of Special Interest to Electrophysiology and Cath Lab Staff/HeartNet
- (February 2008) Of Special Interest to Electrophysiology and Cath Lab Staff/HeartNet
Updated November 23, 2009