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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01510-1
Product Name/Description	Valitude CRT-P, Resonate, Momentum & Autogen CRT-Ds, Visionist CRT-P & Dynagen CRT-D VALITUDE CRT-P Model U128 ARTG 279333 RESONATE CRT-D Model G447 ARTG 296562 MOMENTUM CRT-D Models G124, G125, G126, G128 ARTG 296563, 296564, 296565, 296566 AUTOGEN CRT-D Models G172, G173, G175, G177, G179 ARTG 221615, 221616, 221617, 221618, 221633 VISIONIST CRT-P Models U225, U226, U228 ARTG 279330, 279331, 279332 DYNAGEN CRT-D Models G151, G156, G158 ARTG 221620, 221621, 221622
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 been made aware of unintended asynchronous biventricular (BiV) pacing behaviour when tracking elevated atrial intrinsic rhythms in certain Boston Scientific Cardiac Resynchronisation Therapy (CRT) pacemakers (CRT-Ps) and defibrillators (CRT-Ds). Repeated detection of this unintended asynchronous BiV pacing behaviour may result in the implanted device reverting to a permanent Safety Mode (Safety Core) status thus requiring early replacement.
Recall Action	Recall for Product Correction
Recall Action Instructions	Doctors should review programming records of patients implanted with the CRT devices described in Appendix B of the letter. If the LV Offset parameter is programmed to a Positive value, follow the supplied instructions to determine the need for changing the pacemaker settings. Boston encourages doctors to provide the 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. Maintain awareness of this issue until the software fix becomes available, and display this letter in a prominent place. If a positive LV Offset is desired for a newly implanted Boston Scientific CRT device, consider the patient’s individual medical needs and either program the A-Blank after V-Pace value greater than the positive LV Offset value, or disable Tracking Preference by programming it to a value of “OFF”. This action has been closed out on 14/04/2020
Contact Information	02 8063 8299 - Boston Scientific Technical Services