Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide cardiac resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
Recall
- Recall Number
- Z-1306-2021
- Event Number
- 87261
- Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- FEI Number
- 2182208
- Product Code
- NIK
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- February 3, 2021
- Posted
- March 27, 2021
- Address
- 8200 Coral Sea St Ne, Mounds View, MN, 55112-4391
Description
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide cardiac resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
The firm, Medtronic, issued an "Urgent Medical Device Correction" letter dated February 2021 to its consignees in the United States via UPS 2-day delivery. The letter described the product, problem and actions to be taken. Medtronic recommends the customers do the following: Continue normal follow-up per local clinical protocol. o Recognize that patients who require significant pacing support and high voltage therapy have the lowest risk for this issue - See Appendix A for additional details. o Where possible, take advantage of the CareLink" home monitoring system and the wireless low battery voltage CareAlert. o The low battery voltage audible alert is shipped On with high-urgency tones; Remind patients to contact their clinic if they hear an audible alert, particularly since patients may be opting to delay clinic visits due to COVID-19 guidance. o Inform a Medtronic Representative of any unexpected device behaviors. o Be aware that the inability to interrogate the device, or to transmit data, may be an indicator that the device has experienced this issue. If unexpected RRT is observed, prompt replacement of the device should occur commensurate with the underlying clinical situation of the patient: o For non-pacing dependent patients or for primary prevention ICD patients, replacement within 1 week of an unexpected RRT notification is recommended. o For pacing dependent patients, immediate replacement is recommended following an unexpected RRT notification. Note: For all patients, this issue can also manifest as an unexpected change in the remaining longevity estimate that cannot be attributed to programming changes, or changes in use conditions. Medtronic medical staff in consultation with the IPQP recommends against prophylactic replacement due to the low rate of occurrence and the low potential for permanent harm when prompt replacement occurs in response to an unexpected RRT. Please complete the enclosed Clinician Confirmation Certif
Worldwide Distribution: US (nationwide) Including Puerto Rico and countries of: Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Montenegro, Morocco, Namibia, Nepal, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam Virgin Islands (British), Yemen and Zimbabwe.
238393 units