Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CR

FDA device recall Z-1306-2021 · posted 2021-03-27 · Open, Classified

Recall details

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Reason for recall

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

Action taken

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

Root cause

Device Design

Status

Open, Classified

Product code

NIK

Quantity affected

238393 units

Distribution

Worldwide Distribution: US (nationwide) Including Puerto Rico and countries of: Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bosnia and He

Date initiated

2021-02-03

Date posted

2021-03-27

Location

Mounds View, MN