Field Safety Notice 92705305-FA – High Battery Impedance May Initiate Safety Mode in INGENIO™, VITALIO™, and ADVANTIO™ pacemakers and INLIVEN™, INTUA™, and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-Ps)

 

Affected Medical Device : Invive Implantable Cardiac Resynchronization Therapy Pacemaker

 

MDA Reference Number : MDA/FCA/2021-P081

 

MDA Registration Number : GD93890565918

 

Decription : Dual chamber INGENIO™ family1 pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device’s battery exhibits high internal impedance.

 

Local Establishment Contact Detail :

Nor Syawalia Binti Mohd Nor
Regulatory Affairs Assistant
Boston Scientific (M) Sdn. Bhd.
P: +603 7808 8010
D-36-01, Menara SUEZCAP 1,KL Gateway, No 2 Jalan Kerinchi,Gerbang Kerinchi Lestari,59200 Kuala Lumpur, Malaysia

Email : syawalia.mohdnor@bsci.com

 A copy of FSN.