Potential for early pacemaker replacement due to hydrogen induced premature battery depletion in ACCOLADE Family of Pacemakers and CRT-Ps

Boston Scientific Asia Pacific Pte Ltd would like to notify healthcare professionals of the potential for early replacement of the ACCOLADE Family of Pacemakers and Cardiac Resynchronization Pacemakers (CRT-Ps) - VALITUDE^™ CRT-P, VISIONIST^™ CRT-P, ACCOLADE^™ MRI Pacemakers, ESSENTIO^™ MRI Pacemakers, ACCOLADE^™ Pacemakers, ESSENTIO^™ Pacemakers, PROPONENT^™Pacemakers, and ALTRUA^™ 2 Pacemakers, due to hydrogen induced premature battery depletion.  There have been 34 confirmed hydrogen induced depletion events occurring overseas out of approximately 425,000 distributed pacemakers (1 in 12,500). The theoretical probability for life threatening harm is 0.00004% at 5 years. Boston Scientific has submitted a design change to HSA for inclusion of a polymer within the device to absorb and contain free hydrogen in order to address the issue. In the meantime, healthcare professionals are advised to stop using the unused devices without the polymer material and no further implant of the affected devices should be carried out. Healthcare professionals are also advised to monitor device performance of implanted patients through routine follow-up at 1 day, 1 week, 1 month, 3 months and subsequently 6 months post implant as per clinical practice or clinical needs of the patient, and to promptly investigate alerts or any indication of accelerated battery depletion. Before surgical intervention, Boston Scientific should be contacted to confirm premature depletion of the affected device. Please refer to the letter for details.