ANZCDACC Report: Medtronic Cobalt™ and Crome™ Product Defect Correction October 2021

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

ANZCDACC Advisory Notice 21st Decemember 2016 – Medtronic Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™ Cardiac Resynchronization Therapy Defibrillators (CRT-D) Models DTMB2D1 DTMB2D4 DTMB2QQ DTMA2D1 DTMA2Q1 DTMA2QQ DTMA2D4

Device:  Medtronic  Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™ Cardiac Resynchronization Therapy Defibrillators (CRT-D) Models DTMB2D1 DTMB2D4 DTMB2QQ DTMA2D1 DTMA2Q1 DTMA2QQ DTMA2D4