Medtronic is recalling Cobalt/Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) after receiving reports of devices with a short circuit protection alert resulting in reduced-energy electric shock delivery, instead of delivering a second phase of high voltage therapy.
The U.S. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Medtronic Cobalt/Crome implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators are implantable cardiac devices that are intended to monitor and regulate heart rate and rhythm. These devices can deliver a pacing impulse to correct a slow heartbeat (bradycardia), provide biventricular pacing/cardiac resynchronization therapy, or produce an electric shock (cardioversion or defibrillation) to restore a regular heartbeat if a life-threatening arrhythmia occurs.
A reduced-energy electrical shock from these devices may fail to correct an irregular heartbeat (arrythmia) or may cause an irregular heartbeat. The harms associated with a reduced-energy electric shock or an inaccurate response to a short circuit protection alert may cause serious injury or death.
The recalled product names include the Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). There have been 27 complaints, no injuries, and no deaths associated with this issue.
The recall has affected roughly 87,709 devices, according to the FDA.
Medtronic issued a communication to customers, which offered the following patient management recommendations and considerations to customers and/or users:
- Do not prophylactically replace devices for this issue.
- Remotely monitor patients following normal clinical protocol follow-up.
- Encourage patients to attend their next scheduled follow-up in-clinic for device reprogramming (if necessary).
- Be aware, the following are signs that a short circuit alert is a result of a reduced-energy shock and not a problem with a device’s leads
- If the delivered energy during the episode is ~79% of the programmed energy AND the SCP alert indicates an RV Defib Lead impedance alert reporting exactly zero (0) ohms, this is an indication of a second-phase SCP event (as described in this letter) and not a lead issue.
- Contact Medtronic Technical Services or your local representative if an RV Defib Lead Impedance Alert reporting zero (0) ohms is observed. This is an indicator that an SCP event was detected during HV therapy.