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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01509-1
Product Name/Description Valitude CRT-P, Visionist CRT-P, Accolade Pacemakers and Proponent Pacemakers

Model U128
ARTG 279333

Models U225, U226, U228
ARTG 279330, 279331, 279332

ACCOLADE Pacemakers
Models L310, L311, L331
ARTG 280319, 280315, 280316

PROPONENT Pacemakers
Models L210, L211, L231
ARTG 280320, 280317, 280318
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 20/12/2017
Responsible Entity Boston Scientific Pty Ltd
Reason/Issue Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronisation therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition.
This MV behaviour may occur with any manufacturer’s pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Recall Action Hazard Alert
Recall Action Instructions A software upgrade is being developed for distribution in early 2018. Until this is available to automatically resolve MV sensor signal oversensing, Boston Scientific recommends managing the risk for patients implanted with affected systems as follows:
·Subject to the the guidance supplied to customers, turn the MV sensor to “OFF”
·If transient, abrupt changes or any out-of-range RA/RV pacing impedance measurements are observed, contact Boston Scientific Technical Services to explore all non-invasive programming options prior to surgical intervention
·For patients with the MV sensor enabled, periodically re-assess for pacemaker dependence
Doctors are encouraged to
·Enroll and follow patients using the LATITUDE NXT Remote Patient Management System
·Provide the supplied patient letter to all patients who are implanted with an affected device, and to patients who consent to having the device implanted before the software fix is available

This action has been closed out on 15/04/2020
Contact Information 02 8063 8299 - Boston Scientific Technical Services