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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ IMPLANT COCHLEAR IMPLANT

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ADVANCED BIONICS, LLC HIRES 90K¿ IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1400-01
Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2017
Event Type  Malfunction  
Manufacturer Narrative

Udi number: na.

 
Event Description

The recipient reportedly experienced loss of sound. The recipient's device was explanted. The recipient was reimplanted with another advanced bionics cochlear device.

 
Manufacturer Narrative

The external visual inspection revealed cut silastic overmold along the lead prior to receipt. This is believed to have occurred during revision surgery. The photographic imaging inspection revealed kinked electrode wires. This is believed to have occurred during revision surgery. System lock was verified. The device passed some of the electrical tests performed. The device failed the residual gas analysis test. The internal visual inspection noted silver migration across electrical components. This device had moisture that exceeded the residual gas analysis test limit. The source of the problem was a feedthru hermeticity issue from one feedthru vendor. A capa was implemented. Feedthru assemblies from this vendor are no longer used. This is the final report.

 
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Brand NameHIRES 90K¿ IMPLANT
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
lacey mcdonald
28515 westinghouse place
valencia, CA 91355
6613621741
MDR Report Key7061081
MDR Text Key93107611
Report Number3006556115-2017-00634
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation AUDIOLOGIST
Type of Report Initial,Followup
Report Date 11/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2006
Device MODEL NumberCI-1400-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/20/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/17/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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