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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 Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2018
Event Type  Malfunction  
Event Description

The recipient is reportedly experiencing loss of lock. External equipment was exchanged and programming adjustments were made, however, the issue did not resolve. Revision surgery is under consideration.

 
Manufacturer Narrative

The date of the initial report is corrected to july 12, 2018. The recipient's device was explanted. The recipient was reimplanted with another advanced bionics cochlear device.

 
Manufacturer Narrative

The external visual inspection revealed the electrode was severed prior to receipt. This is believed to have occurred during revision surgery. The device passed the photographic imaging inspection. System lock was obtained intermittently at certain spacing. The lock condition prevented some of the electrical tests from being performed. The device passed some of the electrical tests performed. The device failed the residual gas analysis test. The internal visual inspection noted silver migration around some electrical components. This device had moisture that exceeded the residual gas analysis test limit. Based on an assessment of the residual gas analysis and dye penetrant data, it is believed that this device was non-hermetic and that the root cause of the excessive moisture was a leak through the feedthru seals. A corrective action was implemented. 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
delilah garcia
28515 westinghouse place
valencia, CA 91355
MDR Report Key7744077
MDR Text Key116046402
Report Number3006556115-2018-00355
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 07/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/01/2005
Device MODEL NumberCI-1400-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2018
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 Manufactured08/14/2003
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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