Device product
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.
Z-0399-2018
Product summary
- Event
- Event 77964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,519,984 enrollments total
- Official record key
device-enforcement:Z-0399-2018
Official wording
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.
Code information: Model (UPN/GTIN): 24950 (00643169292284, 00643169292345, 00643169292260, 00643169292529, 00643169292208, 00643169292192, 00643169292222, 00643169292239, 00643169292321, 00643169292215, 00643169292246, 00643169409132, 00643169292253, 00643169292277, 00643169292291, 00643169292307, 00643169292314, 00643169292338); 24950D (643169467163, 00643169441484, 00643169441101, 00643169367173, 00643169367227, 00643169367159, 00643169409156, 00643169367296, 00643169367302, 00643169367258, 00643169367180, 00643169367166, 00643169367210, 00643169367289, 00643169409149, 00643169367197, 00643169367142, 00643169367241, 00643169367203); 24950D1 (00643169486744); 24950E (00643169493667, 00643169493681, 00643169493698, 00643169493674, 00643169451988, 00643169452015, 00643169452107, 00643169452039, 00643169452121, 00643169452008, 00643169452145, 00643169452046, 00643169452022, 00643169452053, 00643169452138, 00643169452060, 00643169451995, 00643169452114, 00643169452152, 00643169452077, 00643169452084, 00643169452091); 24950F (00643169545274, 00643169552074); 24950G (00643169663039 00643169624337, 00643169599987, 00643169599994, 00643169624368, 00643169624351, 00643169624344, 00643169552104); 24950GLQ (00643169552289, 00643169552050, 00643169552067); 24950J (00643169840591, 00643169658011, 00643169658066, 00643169657892, 00643169658073, 00643169786196, 00643169658059, 00643169658028, 00643169658004, 00643169657908, 00643169657915, 00643169657946, 00643169657953, 00643169657960, 00643169657977, 00643169657984, 00643169657991, 00643169657922, 00643169657939, 00643169658042, 00643169658080, 00643169658097, 00643169657885, 00643169705746, 00643169658035); 24950JLQ (00643169658127, 00643169658134, 00643169658141, 00643169947115, 00643169705753); 24950K (00643169725270, 00643169725324, 00643169725201, 00643169725355, 00643169725331, 00643169725317, 00643169725287, 00643169725263, 00643169725294, 00643169725218, 00643169725232, 00643169725249, 00643169725256, 00643169725225, 00643169725300, 00643169725348, 00643169725195); 24950KLQ (00643169725362, 00643169725379, 00643169725386)
Distribution pattern: 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, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom
Derived failure modes
-
Unknown
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.