Cl ll Medtronic Digital implantable cardiac defib

Company: Medtronic Inc.
Date of Enforcement Report 12/1/2010
Class ll:

PRODUCT
1) Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDR). Sterilized using ethylene oxide. The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies. Recall # Z-0110-2011;

2) Medtronic Consulta CRT-D, model D224TRK and Model D234TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDDR). Sterilized using ethylene oxide. The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies. Recall #Z-0111-2011;

3) Medtronic Maximo II CRT-D, model D284TRK. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (VVE-DDDR). Sterilized using ethylene oxide. The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, and ventricular tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF). Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies. Recall # Z-0112-2011;

4) Medtronic Maximo II DR, model D284DRG. Digital dual chamber implantable cardioverter defibrillator (VVE-DDDR). Sterilized using ethylene oxide. The Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, and ventricular tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF). The device responds to bradyarrhythmias by providing bradycardia pacing therapies. Recall # Z-0113-2011;

5) Medtronic Maximo II VR, model D284VRC. Digital single chamber implantable cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide. The Single chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single chamber rate-responsive bradycardia pacing, and ventricular tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy. Recall # Z-0114-2011;

6) Medtronic Secura DR, model D224DRG, and model D234DRG not available in the U.S.. Digital Dual chamber implantable cardioverter defibrillator (DDE-DDDR). Sterilized using ethylene oxide. The Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy. Recall #Z-0115-2011;

7) Medtronic Secura VR, model D224VRC, and model D234VRC not available in the U.S.. Digital single chamber implantable cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide. The Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy. Recall # Z-0116-2011;

8) Medtronic Virtuoso DR, model D274DRG, and model D294DRG not available in the U.S.. Digital Dual chamber implantable cardioverter defibrillator (DDE-DDDR). Sterilized using ethylene oxide. The Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy. Recall # Z-0117-2011;

9) Medtronic Virtuoso VR, model D274VRC, and model D294VRC not available in the U.S. Digital Single chamber implantable cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide. The Single chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single chamber rate-responsive bradycardia pacing, and ventricular tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy. Recall # Z-0118-2011
defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy. Recall # Z-0117-2011;

REASON
DMedtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. In the unlikely event that this sequence occurs, all subsequent high voltage therapies will experience prolonged charge time or loss of high voltage therapy (due to a charge circuit timeout). Device alerts are nominally ON and will notify patients to seek medical attention should either of these alert conditions occur.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by letter dated May 2010 beginning May 05, 2010.
Manufacturer: Medtronic Puerto Rico Operations Co., Juncos, PR;
Medtronic Swiss Manufacturing Facility, Tolochenaz, Switzerland. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
143,900 implanted

DISTRIBUTION
Nationwide and Internationally

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.