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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-1400-02H
Device Problem Impedance Problem (2950)
Patient Problem Hearing Impairment (1881)
Event Date 10/05/2017
Event Type  Malfunction  
Manufacturer Narrative

Udi number: na.

 
Event Description

The recipient reportedly experienced loss of sound and invalid impedances. External equipment was exchanged, however, the issue did not resolve. The recipient's device was explanted. The recipient was reimplanted with another advanced bionics cochlear device.

 
Manufacturer Narrative

The date of this report is corrected to 12/08/2017.

 
Manufacturer Narrative

The external visual inspection revealed the electrode array was severed prior to receipt as well as a damaged silastic overmold on the bottom cover. This is believed to have occurred during revision surgery. The device passed the photographic imaging inspection. System lock could not be obtained at any spacing. The no lock condition prevented some of the electrical tests from being performed. The device passed some of the electrical tests performed. The device passed the mechanical test performed. This is an interim report.

 
Manufacturer Narrative

The external visual inspection revealed the electrode array was severed prior to receipt as well as damaged silastic overmold on the bottom cover. This is believed to have occurred during revision surgery. The device passed the photographic imaging inspection. System lock could not be obtained at any spacing. The no lock 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 internal hybrid visual inspection revealed non-conductive epoxy encroachment on an electrical component. The failure of this device is attributed to a short from a power node to the electrode ground case at the analog chip. It is believed that electrostatic discharge (esd) led to an overload voltage, damaging structures on the electrode ground node inside the analog integrated circuit. This ultimately caused the device to cease functioning. In addition, a significant drop in signal strength as well as elevated resistance was measured across an electrical component joint. Corrective actions were 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
6613624711
MDR Report Key7152185
MDR Text Key95965285
Report Number3006556115-2017-00714
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,HEALTH PROFESSIONAL
Reporter Occupation AUDIOLOGIST
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/01/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL NumberCI-1400-02H
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/13/2018
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 Manufactured02/20/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/28/2017 Patient Sequence Number: 1
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