24 November Addendum to ANZCDACC Advisory Notice 12 November 2015

Device: St Jude Optisure Dual Coil Defibrillation Leads

Models: LDA220Q/52, LDA220Q/58, LDA220Q/65 and LDP 220Q/58

Advisory Grade TGA: TBA however likely Class I

ANZDACC Advisory Grade: Semi-urgent

Number in Australia: 19 implanted in Australia. Zero in New Zealand

The Committee has just become aware that not all the patients with the above advisory leads are on home monitoring as previously advised. It is the Committee’s opinion that all patients with the advisory lead insitu should where possible go onto home monitoring. If home monitoring is not possible increased in office monitoring on a 3 monthly basis would be appropriate.