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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 048 11 15 000
Date submitted: 11/10/2015
Manufacturer:St. Jude Medical Inc
Device Type:Optisure™ Dual Coil Defibrillation Leads
Description: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
Remedy Action:-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.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:D42CDDDD2A2E4
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: St. Jude Medical Inc.pdf