Device Recall Advanced Bionics HiRes 90K Cochlear Implant device 의 리콜

Recall

57349

Class 2

Z-0796-2011

2010-11-23

2010-12-21

Terminated

United States

2012-03-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95925

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.

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