ANZCDACC Advisory Notice 6th December 2020

ANZCDACC Advisory Notice 6th December 2020

Device:  Medtronic Cobalt™ and Crome™ ICD and CRT-D

Advisory grade TGA: Urgent Product Defect Correction

ANZDACC Advisory Grade: Routine

Description:
The of Ventricular fibrillation anti-tachycardia pacing (VF- ATP) parameter in these devices may not be automatically enabled and may require manual programming and as such may inadvertently be set to off.

Number of devices affected in Australia and New Zealand:
Australia: and New Zealand: TBA

Presentation:
Patient may present with high voltage therapies which were previously treated with ATP

Rate of occurrence:
1 incidence out of 3,237 devices implanted worldwide related to this advisory issue. No serious adverse events have been reported.  These devices will deliver all programmed high-voltage therapies as programmed, regardless of the VF ATP parameter setting being off. The issue is risk for a high-voltage therapy to be applied for a Fast VT arrhythmia in the VF detection zone, which could have been treated with ATP during Charging.

Recommendation:
Confirm the appropriate selection has been programmed for the VF ATP parameter at implant.

At routine follow-up, confirm that the VF ATP parameter is programmed to the desired setting for each patient.


The ANZCDACC encourage you to report any adverse event or near (potential) adverse event associated with the use of a medical device including any abnormal CIED or lead function. We encourage reporting to ANZCDACC directly via the Committee chair Dr Paul Gould drpgould@gmail.com and to the following regulators.

In Australia, report to the TGA;
Online: https://www.tga.gov.au/reporting-problems

In New Zealand, report to Medsafe;

Post Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6145.
Email devices@moh.govt.nz
Fax 04 819 6806