BEUDAMED
    FDA Recall Terminated

    S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.

    Recall: Z-0959-2009 · Initiated July 24, 2008

    Recall

    Recall Number
    Z-0959-2009
    Event Number
    50204
    Firm
    Advanced Bionics LLC
    FEI Number
    3006556115
    Product Code
    MCM
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 24, 2008
    Posted
    February 3, 2009
    Terminated
    March 23, 2012
    Address
    12740 San Fernando Rd, Sylmar, CA, 91342-3728

    Description

    S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.

    Reason

    Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cann

    Action

    Advanced Bionics is notifying clinicians of this situation so that they can provide appropriate clinical management. The notification letter sent to clinicians in the United States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are not affected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Since discovery of this issue firm has conducted an extensive technical analysis showing that the use of these headpieces does not pose any safety risk to the patient. While there has been no increase in the number of headpiece-related complaints, firm advises of the potential clinical symptoms: -No lock -Intermittent lock -Implant locks, but cannot measure impedances -Reduction in battery life, primarily for C1 patients with thick flaps. Per the letter, as long as the system maintains lock, there is no degradation in sound quality or stimulation. Further, the impact on battery life for CII and HiRes 90K patients is minimal. Medical professionals are advised that If they have any patients who display any of these clinical symptoms that they attribute to an affected headpiece, to advise the patient to contact Advanced Bionics Customer Service at 877-244-9541 and they will send them a replacement promptly.

    Distribution

    Nationwide

    Quantity

    MMT-5300-10: 118 units; MMT-5300-00: 76 units