Issued : October 10, 2007
Dear Healthcare Provider:
This is to remind you of the increased, life-threatening risk of bacterial meningitis in cochlear implant recipients and the importance of fully immunizing these patients. Although all cochlear implant recipients appear to be at some increased risk of bacterial meningitis caused by Streptococcus pneumoniae, those children implanted with cochlear implants that have a positioner are at greatest risk. The only model with a positioner was withdrawn from the market in July, 2002.
Recent deaths
FDA has become aware of two deaths from meningitis within the past year in children implanted with the cochlear implant with positioner. Neither of these children was fully immunized according to the CDC recommended vaccination schedule (see link below). These children, ages 9 and 11, had completed only part of the recommended pneumococcal vaccinations for their age group. At least one of these children had meningitis caused by a serotype of Streptococcus pneumoniae that may have been prevented by proper vaccinations.
Failure to immunize
A recent survey of the Johns Hopkins University cochlear implant patient population, conducted by Dr. John Niparko, revealed that despite repeated information bulletins from the University regarding the importance of vaccination, 29% of the parents/guardians of patients under 2 years of age were uncertain of the child’s vaccination status. Vaccination status was unknown in 43% of children older than two years, and 12% were known to be not properly vaccinated. These findings strongly suggest that patients are not receiving vital preventive care that can reduce their risk of this life-threatening illness. FDA is working with the CDC, cochlear implant manufacturers, and professional societies to heighten awareness of the importance of vaccinations in the cochlear implant population.
Recommendations to decrease the risk of meningitis in cochlear implant recipients
Advice to Patients with Cochlear Implants can be found at http://www.fda.gov/cdrh/medicaldevicesafety/atp/101007-cochlear.html.
Additional background information
The original CDC/FDA article on this topic was published in the July 31, 2003 issue of The New England Journal of Medicine (http://content.nejm.org/cgi/content/full/349/5/435). The original FDA Notifications on the Risk of Bacterial Meningitis in Children with Cochlear Implants, can be found at http://www.fda.gov/cdrh/safety/cochlear.html and http://www.fda.gov/cdrh/safety/020606-cochlear.html. The earlier FDA Notifications include additional background information not included in this update.
Reporting cases of meningitis in cochlear implant recipients
We encourage you to report cases of meningitis in cochlear implant recipients. You can report cases directly to the device manufacturer or to MedWatch, FDA’s voluntary reporting program. This can be done on line at www.fda.gov/MedWatch/report.htm, by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by returning the postage-paid FDA form 3500 which may be downloaded from www.fda.gov/MedWatch/getforms.htm. You can also report by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
Contacting FDA
If you have questions about this notification, please contact Nancy Pressly, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.
FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html . You can also be notified through e-mail each time a new Public Health Notification is added to our web page. To subscribe to this service, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10.
Sincerely yours,
Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Updated October 10, 2007
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