FCA Report_CVG-22-Q1-02 Reveal LINQ with TruRhythm™ Insertable Cardiac Monitoring Systems

 

Affected Medical Device : Reveal and Reveal LINQ Insertable Cardiac Monitor

 

MDA Reference Number : MDA/FCA/2021-P075

 

MDA Registration Number : GD89249865118

 

Decription : Medtronic has identified that Reveal LINQ with that undergo a partial electrical reset appear to be programmed “ON,” but are no longer able to detect and report Brady and Pause events. A partial electrical reset is normal behavior that can occur when the device detects a possible issue with the device software.

 

Local Establishment Contact Detail :

Wong Wai Yi
Medtronic Malaysia Sdn Bhd
B-23-01, The Ascent, Paradigm, No. 1, Jalan SS7/26A, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia
Office +603-78838000|

Email : wong.waiyi@medtronic.com

 A copy of FSN.