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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 077 10 16 002
Date submitted: 10/12/2017
Manufacturer:St. Jude Medical Inc
Device Type:Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra
Description:Implantable Cardioverter Defibrillator
Medical Device Identifier:Models: CD1233-40, CD1233-40Q, CD1235-40, CD1235-40Q, CD1259-40, CD1259-40Q, CD1299-40 .. (See APPENDIX for details)

FDA Update
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q

Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q
Reason of Field Safety Corrective Action:Premature Battery Depletion with Implantable Cardioverter Defibrillator
Remedy Action:- Do not implant unused affected devices.

- Conduct patient follow-up per standard practice.

- Prophylactic device replacement is NOT recommended because complications following replacement have been reported to occur at a greater rate than the rate of harm associated with premature battery depletion due to lithium cluster induced shorts (see appendix for selected references).

- In the event of an ERI indicator in these devices, immediate device change is recommended. At this time there is no factor, method or test to identify devices with this form of premature battery depletion approaching ERI or to accurately predict remaining battery life once ERI appears.

- Physicians should reaffirm the availability of home monitoring to avoid or minimize time without device therapy for bradycardia and tachycardia events.

- Enroll patients in Merlin.net utilizing the “Direct Alerts” feature to provide you with an immediate alert notification in the event ERI is reached. For patients currently enrolled in Merlin.net, remind them of the importance of using remote monitoring.

- Review the most recent Programmed Parameters printout (see attached for an example).

- Ensure that under the “Trigger Alerts When” section, that the “Device at ERI” parameter is ON (it is normally ON) for both “Show on FastPath” and “Notify Patient” selections.

- If the “Device at ERI” alert is OFF, we recommend that the patient be seen promptly to program this parameter ON.

- Advise patients that an ERI indication triggers a vibratory alert. At the next scheduled office visit:

- Interrogate the patient’s device to determine if an ERI alert has been triggered. Premature battery depletion can be identified by physicians through home monitoring showing ERI or more advanced battery depletion.

- Perform a patient notifier test to confirm that the patient feels and recognizes the vibratory alert.

- Patients who cannot feel the vibratory alert may experience loss of battery and/or loss of device function without their awareness.

- Advise the patient to contact your office promptly should they feel a vibratory alert.

- In-office evaluation should be performed to determine the reason for the alert as other noncritical events can also trigger a vibratory alert.

Your St. Jude Medical representative will replace any affected inventory you may have at your center(s). To determine if a device serial number is subject to this advisory, please go to the following website: www.sjm.com/batteryadvisory

NCMDR Updated action:
• The manufacturer has developed a new management tool for patients who have Impacted Devices, in order to provide an earlier notification of abnormal battery performance that may lead to premature battery depletion due to short circuits from lithium clusters. This tool is not currently available, but will be launched in your region following local regulatory approval. • Updated Patient Management Recommendations (See attached file)

FDA Update

Abbott sent a Field notification to customers of the availability of the new Battery Performance Alert.
The link to the statement is as follows: http://abbott.mediaroom.com/2017-08-29-Abbott-issues-new-updates-for-implanted-cardiac-devices
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:5399F801191FE, 438173A9011E1 , Z-0003-2018, Z-0004-2018
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments