Medtronic, Inc.KRGClass III

Programmer, Pacemaker

Medtronic, Inc.'s record for this product code

MDR events20,612All time

Recalls2All time

510(k) clearances0All time

Recent MDR events

20,612 adverse event reports on file

Recalls

2 recall events for this product code

Open, ClassifiedJul 17, 2025
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
View FDA record ↗
Open, ClassifiedJul 17, 2025
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
View FDA record ↗

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for Medtronic, Inc. under this product code.