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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 094 09 18 000
Date submitted:	9/20/2018

Manufacturer:	Boston Scientific Cardiac Rhythm Management Group
Device Type:	Cardiac Resynchronization Therapy pacemakers (VISIONIST™, ™,) and pacemakers (ACCOLADE™, PROPONENT™ and ESSENTIO™)
Description:	pacemakers
Medical Device Identifier:	ACCOLADE™ & ACCOLADE™ MRI : L300, L301, L321 & L310, L311, L331 L200, L221 & L210, L211, L231 ESSENTIO™ & ESSENTIO™ MRI : L100, L101, L121 & L110, L111, L131 VISIONIST™ X4 : U228 VALITUDE™ X : 4 U128
Reason of Field Safety Corrective Action:	The pacemaker manual describes how increases in pacing requirements or changes in programmed parameters may result in an expected longevity reduction and are considered normal battery depletion. However, hydrogen exposure within the pacemaker’s circuitry may compromise the electrical performance of low voltage capacitors causing current leakage and a moderate acceleration in the rate of battery depletion. Because this accelerated depletion does not occur rapidly, a follow-up interval of no more than six months is recommended. Boston Scientific has determined a liner component to be the source of hydrogen and identified a subset of previously distributed pacemakers that have an elevated potential for exhibiting this behavior. Boston Scientific pacemakers include automated diagnostic tools, including battery status assessment and estimated longevity predictions, that dynamically adjust based on power consumption. It is important to emphasize that the accuracy of battery status and longevity estimates are not affected by this behavior.
Remedy Action:	Boston Scientific recommends following patients implanted with any affected pacemaker from the advisory subset at intervals no greater than every six (6) months either in-clinic or via LATITUDE in accordance with the best practices outlined in international societal guidelines1. Appendix A provides guidance for healthcare professionals in determining accelerated battery depletion. Promptly investigate any suspected indication of accelerated depletion. Before surgical intervention, contact Boston Scientific Technical Services for verification of accelerated depletion and to determine an appropriate timeframe for pacemaker replacement. Please note, if accelerated depletion is identified, the Save to Disk feature or LATITUDE is necessary to perform an engineering assessment. Prophylactic replacement is NOT recommended for pacemakers with normal battery consumption as the risk of surgical replacement outweighs the risk of accelerated depletion.
Athorized Representative/Importer/Distributor:	FAROUK, MAAMOUN TAMER & COMPANY
Report Source:	NCMDR
Source Ref. Number:	0CFE2AAB31210
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Boston Scientific .pdf

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