According to a recall announcement published by the United States Food and Drug Administration, Medtronic is recalling its Medtronic Cobalt XT, Cobalt and Crome Implantable Cardioverter Defibrillators (ICDs), and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). The implantable cardiac devices can malfunction, causing injuries and deaths. The FDA has identified the recall as a Class I recall, which is the most severe type of recall. A Class I recall warns consumers that the affected products could cause serious injuries or death. This recall affects nearly 88,000 implantable cardiac devices.
The medical devices that are involved in this recall include Medtronic’s Cobalt XT, Cobalt and Crome implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The recalled implantable cardiac devices were distributed to medical clinic providers from February 3, 2020, until the present day. According to the recall notice, this recall was started after Medtronic discovered short circuit protection (SCP) alerts that were forcing the medical devices to transmit reduced-energy electric shocks.
The FDA’s advisory stated that reduced-energy electrical shock could fail to rectify irregular heartbeats (arrhythmia) or could cause an irregular heartbeat. Serious injury or death can occur when an inaccurate response to an SCP alert or a reduced-energy electric shock happens. There have been 27 incident reports concerning these recalled products.
Medtronic Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) are implantable cardiac medical devices that are designed to regulate and monitor heart rhythm and heart rate. These medical devices deliver a pacing impulse that corrects a slow heartbeat (also known as bradycardia), produces an electric shock (defibrillation or cardioversion) to restore a regular heartbeat when a life-threatening arrhythmia happens, or provide cardiac resynchronization/biventricular pacing therapy.
Medtronic is recalling Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Resynchronization Therapy Defibrillators (CRT-Ds) after the company received incident reports of devices with short circuit protection (SCP) alerts sending reduced-energy electric shock delivery, instead of sending a second phase of high voltage therapy.
These devices send reduced-energy electrical shocks that fail to correct an irregular heartbeat (arrythmia) and can cause a dangerous irregular heartbeat. The harm connected to an inaccurate response to an SCP alert or a reduced-energy electric shock happens, the patient could endure serious injury or death.
Medtronic has issued a communication to customers concerning the issue. The safety communication proposed the following patient management recommendations:
- Don’t “prophylactically” replace devices for this problem.
- Monitor patients remotely after a normal clinical protocol follow-up.
- Motivate patients to attend their next follow-up appointment for in-clinic device reprogramming (if required).
- Program all high voltage therapies to 40J with a B>AX pathway and Active Can/SVC Coil set with Active Can enabled across all therapy zones.
- The necessary software update will be ready in late 2022.
- The following symptoms are that of a short circuit alert resulting in a reduced-energy shock and are not an issue with the device’s leads.
- If the delivered energy during an episode is ~79% of the programmed energy and the SCP alert shows an RV Defib Lead impedance alert of zero (0) ohms, this suggests a second-phase SCP event (described in the letter) and is not a lead problem.
- Contact Medtronic Technical Services or your local representative should an RV Defib Lead Impedance Alert reporting zero (0) ohms appear. This could be an indicator that an SCP event occurred during HV therapy.
- Consider device replacement solely after confirming and observing SCP events with a Medtronic representative.
- There are several device functions are not impacted following an SCP alert:
- Anti-tachycardia pacing therapies
- Battery longevity
- Bluetooth telemetry
- Episode detection
- High voltage charging
Customers who have questions about this recall can contact Medtronic Technical Services or their Medtronic representative.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Did you or a loved one sustain harm due to a defective medical device? Parker Waichman LLP helps those who have suffered product injuries receive full monetary compensation. Trust your case with our product injury lawsuit lawyers. For a free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation