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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 048 11 15 000
St. Jude Medical Inc
Optisure™ Dual Coil Defibrillation Leads
Medical Device Identifier:
Models: LDA220Q/52, LDA220Q/58, LDA220 Q/65 and LDP 220Q/58
Reason of Field Safety Corrective Action:
Potential insulation damage at the interface of the termination sleeve and SVC shock coil in Optisure™ Dual Coil Defibrillation leads
-For patients implanted with St. Jude Medical ICD/CRTD we recommend at your patient’s next follow up visit a St. Jude Medical representative be present to program an alert message in the implanted device.
-When set up, this alert will enable Clinicians following patients with impacted subject leads to receive the alert message on the Merlin™ Patient Care System Programmer upon interrogation, ensuring that future caregivers assessing the diagnostics of these devices receive the latest information and be made aware of this corrective action.
-The programmer alert will direct clinicians to this letter for additional information. We believe such actions will further the ability of our clinician partners to most optimally manage the care of their patients.
Al-Jeel Medical & Trading Co. LTD
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
St. Jude Medical Inc.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.