Recall Z-0400-2018 ยท NVZ Pulse Generator, Permanent, Implantable
Medtronic Inc., Cardiac Rhythm and Heart Failure
MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device
| Date | Jul 14, 2017 |
| Status | Terminated |
| Reason | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports. |
| Root cause | Error in labeling |
| Action | Customers were notified via letter on 07/14/2017. Medtronic communicated that an updated Clinician Instructions for Use has been released with the following updated information: In patients with more than one Medtronic implanted hear device, device data may not be able to transmit from any of the implanted devices to the physician via the Monitor; The patient could potentially transmit device data unintentionally from one of the implanted heart devices when attempting to transmit from another device implanted in the same patient; and a Medtronic Programmer can be used to obtain data from ea |
| Quantity | 1,519,984 enrollments total |
| Distribution | Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Internationally: Austria, Belgium, Brunei, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lithuania, Malaysia, Malta, Netherlands, Norwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.