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U.S. Department of Health and Human Services

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

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ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1500-01
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)
Event Date 10/18/2017
Event Type  Malfunction  
Event Description

The recipient is reportedly experiencing facial nerve stimulation and pain with device use. External equipment was exchanged and programming adjustments were made, however, the issue did not resolve. Revision surgery is under consideration.

 
Manufacturer Narrative

Programming adjustments were made once again, which resolved the issue. However, the recipient continues to be monitored.

 
Manufacturer Narrative

Revision surgery will be scheduled.

 
Manufacturer Narrative

The external visual inspection revealed the electrode was severed near the fantail, and damaged silicone overmold was observed on the bottom cover prior to receipt. These are believed to have occurred during revision surgery. The device passed the photographic imaging inspection. System lock was verified. The electrode condition prevented some of the electrical test from being performed. The device passed some of the electrical test performed. The device passed the mechanical tests performed. This is an interim report.

 
Manufacturer Narrative

The recipient was explanted. The recipient was reimplanted with another advanced bionics cochlear device.

 
Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed. The recipient's activation went well. The external visual inspection revealed the electrode was severed near the fantail and damaged silicone overmold was observed on the bottom cover prior to receipt. These are believed to have occurred during revision surgery. The device passed the photographic imaging inspection. System lock was verified. The electrode condition prevented some of the electrical tests from being performed. The device passed some of the electrical tests performed. The device passed the mechanical tests performed. The residual gas analysis revealed nitrogen above the limit indicating a non-hermetic device. Due to the presence of moisture getter, no signs of moisture were observed. This is believed not to be related to the return reason. The failure of this device is attributed to a short from the power node to the case ground at the analog chip. It is believed that electrostatic discharge (esd) led to an overload voltage, damaging structures on the case ground node inside the analog integrated circuit. This ultimately caused the device to cease functioning. A corrective action was implemented. This is the final report.

 
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Brand NameHIRES 90K¿ ADVANTAGE 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
6613621741
MDR Report Key7142977
MDR Text Key95851362
Report Number3006556115-2017-00707
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2015
Device MODEL NumberCI-1500-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/12/2013
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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