Archived – Recall Notification for All Unused Advanced Bionics Implantable Cochlear Stimulators – Advanced Bionics

Starting date:

September 27, 2004

Posting date:

November 9, 2004

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-17000745

This is duplicated text of a letter from Advanced Bionics.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on the CLARION^® 1.2, CLARION^® CII, and HiRes™90K cochlear implants.

September 27, 2004

Subject: Urgent Recall Notification for the CLARION^® 1.2, CLARION^® CII, and HiRes™90K cochlear implants.

Dear Clinicians:

Advanced Bionics is asking you to return, immediately, all unused Advanced Bionics implantable cochlear stimulators: the CLARION^® 1.2, the CLARION^® CII, and the HiRes™90K. The recall arises from our concern about the possible presence of residual moisture in, or a potential loss of hermeticity of, the implantable cochlear stimulators. This recall is being made with the knowledge of Health Canada.

Advanced Bionics has conducted a review of the reliability rates and failure modes of these products, which has led to this action. We would like to share the results and our decisions.

• The CLARION^® 1.2, the oldest of the three models, is still in use by 92.0% of the recipients after 5 years. The CLARION^® CII remains in 97.7% of patients after 3 years. While some of these devices have been removed for medical reasons (such as infection), most simply stopped working. Our investigation into these failures indicates that the most common cause was moisture in the stimulator that resulted in a premature loss of function.
• The HiRes™90K, our newest model, has had an explant rate of 1.1% at 12 months. Roughly half of these have been for medical reasons. Our investigations of the failures indicate that, in at least one instance, a significant cause was unexplained moisture on the internal circuitry. We have also found some residual moisture in other units that were hermetically sealed, although we have not yet determined whether these devices were affected by the moisture.
• Advanced Bionics is taking additional steps to reduce and control moisture levels in new units of the HiRes™90K cochlear stimulator. We do not know how long this process will take, but until it is completed, we will not be able to supply cochlear implants. Please be assured that we are working on these improvements as quickly as possible. If you have a candidate scheduled for cochlear implant surgery, we recommend that you use a cochlear implant from another manufacturer or postpone implant surgery. We regret the inconvenience this interruption will cause you and your patients.

In addition, Advanced Bionics will soon be writing each cochlear implant user about the possibility of premature failure. Your patients may contact you with questions or for counselling, so we wanted you to be aware of the information in our letter before it is sent to users. They will be told that the signs and symptoms of failure are a sudden sensation of discomfort or pain, a sudden loud noise or popping sound, an intermittent functioning, a complete loss of sound, and in children, an unwillingness to wear the external headpiece. They will be advised that, if they experience any of these signs or symptoms, they should first try the backup cable, then the backup headpiece (if separate), and then the backup sound processor. If the signs or symptoms persist, they will be advised to remove the headpiece and contact their hearing care providers. They will be told that hearing clinics have a simple and quick way to test whether the implanted cochlear stimulator is fully functional.

If you have any questions regarding this letter, please call the Advanced Bionics implant hotline at 1-877-454-5038 between the hours of 5 AM and 5 PM Pacific Time, Monday through Friday.

Centers that we have shipped devices to, but where the implant registrations are outstanding, will receive a list of those devices with the serial number and shipment date. The document will be sent no later than September 28, 2004, close of business and will provide the information on how to return the products. It is important that the device registration and the product return be handled expeditiously.

Thank you in advance for your cooperation on this matter and we apologize for the inconvenience.

Sincerely,

original signed by

Jeffrey H. Greiner
President and Co-Chief Executive Officer

The identification, characterization, and management of medical device-related adverse incidents are dependent on the active participation of health care professionals in adverse incident reporting programmes. Any occurrences of serious and/or unexpected adverse incidents in patients using the CLARION^® 1.2, the CLARION^® CII, and the HiRes™90K should be reported to Health Canada at the following address:

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675

For other inquiries: please refer to contact information.

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.