Nucleus N5 CI500 series implant recall: Hard failure rate at a major cochlear implantation center

Hildrew, D.M. and Molony, T.B. (2013) Nucleus N5 CI500 series implant recall: Hard failure rate at a major cochlear implantation center. Laryngoscope, 123 11: 2829-2833. doi:10.1002/lary.24149

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Author Hildrew, D.M.
Molony, T.B.
Title Nucleus N5 CI500 series implant recall: Hard failure rate at a major cochlear implantation center
Journal name Laryngoscope   Check publisher's open access policy
ISSN 0023-852X
1091-756X
Publication date 2013-01-01
Sub-type Article (original research)
DOI 10.1002/lary.24149
Volume 123
Issue 11
Start page 2829
End page 2833
Total pages 5
Place of publication Hoboken, NJ, U.S.A.
Publisher John Wiley & Sons, Inc.
Language eng
Subject 2733 Otorhinolaryngology
Abstract Objectives/Hypothesis To compare the cumulative failure percentage of the Cochlear Nucleus N5 CI500 series implant observed, both before and after the voluntary recall of unimplanted devices, to that of the Cochlear Nucleus Freedom CI24RE series implant. Study Design Retrospective review of 411 patients implanted with either the Nucleus Freedom or the Nucleus N5 device. Methods Cochlear implantation was performed in standard fashion. A database was created by combining information obtained from operative case logs, an integrated clinical electronic medical records system, and an external database of devices maintained by Cochlear Corporation. Results Of the 289 implants of the Nucleus Freedom CI24RE series device at this institution, the cumulative failure percentage was 0%. There were 122 implants of the Nucleus N5 CI500 series device, yielding a 9.8% cumulative failure percent; 82 were manufactured before the voluntary recall and 40 were produced afterward. The 82 implants manufactured before the recall had two associated failures, while the 40 produced afterward had 10 failures. Conclusions It is possible that the cumulative failure percentage (CFP) of the Cochlear Nucleus N5 CI500 series implant is not fully defined. While the CFP of the Nucleus Freedom CI24RE series implant at this institution was 0%, it was 9.8% for the Nucleus N5. The CFP of Nucleus N5 devices manufactured before the voluntary recall was 2.4%, while the CFP afterward was 25.0% - nearly 6-fold higher than the company-published value of 4.2% for all Nucleus N5 implants registered globally. Copyright
Keyword CI24RE
CI512
Cochlear implant
cumulative failure percentage
diode
hard failure
hermetic seal
hermeticity
microcrack
Nucleus Freedom
Nucleus N5
recall
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2014 Collection
School of Medicine Publications
 
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Created: Mon, 24 Feb 2014, 23:10:44 EST by Matthew Lamb on behalf of School of Medicine