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U.S. Department of Health and Human Services

Class 2 Device Recall Advanced Bionics HiRes 90K Cochlear Implant device

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  Class 2 Device Recall Advanced Bionics HiRes 90K Cochlear Implant device see related information
Date Initiated by Firm November 23, 2010
Date Posted December 21, 2010
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-0796-2011
Recall Event ID 57349
PMA Number P960058S030 
Product Classification Implant, cochlear - Product Code MCM
Product Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-02H

The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.
Code Information Serial Numbers:  352454 352743 352779 352908 353919 355514 355618 355700 355876 355889 356171 356180 356206 356361 356477 356561 356723 356746 356891 356900 356910 357104 357153 357171 357249 357265 357341 357417 357426 357452 357464 357490 357525 357548 357621 357645 357681 357687 357692 357696 357711 357772 357784 450211 450257 450346 450350 450363 450457 450487 450489 450495 450498 450511 450517 450521 450523 450525 450527 450530 450534 450535 450541 450545 450550 450552 450555 450559 450566 450567 450573 450581 450590 450624 450628 450661 450706 450721 450724 450727 450735 450817 
Recalling Firm/
Manufacturer		 Advanced Bionics Corporation
12740 San Fernando Rd
Bldgs. 1 & 3
Sylmar CA 91342
For Additional Information Contact Cheryl Garma
661-362-1400
Manufacturer Reason
for Recall		 The recall action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.
FDA Determined
Cause 2		 Pending
Action Advanced Bionics (AB) Personal contacted all centers with known surgeries about the recall by telephone on November 22, 2010, and sent Blastfax to affected surgeons and clinicians. AB forwarding a Press Release on November 23, 2010 to the Business Wire News Trak. The firm also faxed Health Care Provider letters to the affected Health Care Providers and placed a Patient notification letter on the AB website on November 23, 2010. Health Care Provider letters were FedEx'ed November 24, 2010 to the affected Health Care Providers. Patient Letters were sent via FedEx'ed beginning Monday November 29th and 30th to approx. 10,500 patients. A Recall Acknowledgement Form was included for each recipient to sign as proof that the notification has been read. The press release & recall letter informed the patients/consignees of the reason for recall, the product affected and the potential hazard involved. The Health Care Provider letter also requested providers with recipient under their care who reports pain, overly loud sounds, or sudden shock sensations while the implant is powered to follow these steps: 1. Advise them to remove the external equipment immediately, 2. Schedule an appointment to complete standard troubleshooting steps listed in the AB Sound Processor User Guide, 3. If standard troubleshooting does not resolve the issue, please contact Advanced Bionics for additional troubleshooting steps that may assist in determining the presence of recall problem, 4. If your evaluation of the patient's condition suggests that the implant exhibits this problem, device explantation and replacement is advised. In addition, the Health Care Provider letter informed providers that if AB records show that you have any unregistered implants in their possession, a list of serial numbers has been provided for devices that must be returned to Advanced Bionics. If no unregistered implants have been identified, no list will be enclosed. The Patient letter also
Quantity in Commerce 82 units
Distribution Nationwide distribution: AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MCM and Original Applicant = ADVANCED BIONICS
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