Jun 2021 : Notification of Field Action: INGENIO 2 (ESSENTIO, PROPONENT) PACEMAKER, Ingenio 2 (Valitude, Valitude X4, Visionist, Visionist X4 CRT-P)
Notification of Field Action: INGENIO 2 (ESSENTIO, PROPONENT) PACEMAKER, Ingenio 2 (Valitude, Valitude X4, Visionist, Visionist X4 CRT-P)
Affected Medical Device :
1. INGENIO 2 (ESSENTIO, MRI PROPONENT MRI PACEMAKER)
2. Ingenio 2 (Valitude, Valitude X4, Visionist, Visionist X4 CRT-P)
MDA Reference Number : MDA/FCA/2021-P080
MDA Registration Number :
1. GD97300566018
2. GD98324339517
Decription : Potential for Safety Mode due to increase in battery impedance prior to replacement indicators. And ACCOLADE, PROPONENT™, ESSENTIO™, and ALTRUA™ 2 pacemakers and VISIONIST™ and VALITUDE™ CRT-Ps (subset) – Elevated likelihood for early replacement due to accelerated battery depletion.
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 : [email protected]
