Device:
All Medtronic Cobalt™ and Crome™ ICDs and CRTDs. Namely:
Cobalt™:
Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DDPA2D4; Cobalt DR: DDPB3D1, DDPB3D4; Cobalt XT HF: DTPA2D4, DTPA2D1; Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1; Cobalt HF: DTPB2D4, DTPB2D1; Cobalt HF Quad: DTPB2QQ, DTPB2Q1
Crome™:
Crome VR: DVPC3D1, DVPC3D4; Crome DR: DDPC3D1, DDPC3D4; Crome HF: DTPC2D4, DTPC2D1; Crome HF Quad: DTPC2QQ, DTPC2Q1
TGA /Medsafe Reference:
Australian Register of Therapeutic Goods (ARTG): 313620
Medsafe Reference: 28468
Advisory grade TGA:
Not listed on TGA website but likely Class II
(Class II recall action occurs when the product deficiency could cause illness, injury or result in mistreatment, but are not class I.)
ANZDACC Advisory Grade: Routine