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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-1500-02H
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 02/15/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The recipient is reportedly experiencing pain with device use. The external equipment was exchanged and programming adjustments were made, however, the issue did not resolve. The recipient ceased device use. Revision surgery is scheduled.

 
Manufacturer Narrative

The recipient's device was reportedly explanted. The recipient was reimplanted with another advanced bionics device. Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

 
Manufacturer Narrative

The device passed the external visual inspection. The photographic imaging inspection revealed two broken electrode wires at the fantail region. This is believed to have occurred during revision surgery. System lock was verified. The broken electrode wires 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 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 chip 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
lacey mcdonald
28515 westinghouse place
valencia, CA 91355
6613621741
MDR Report Key7152181
MDR Text Key95968989
Report Number3006556115-2017-00702
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
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 Date02/28/2019
Device MODEL NumberCI-1500-02H
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/23/2018
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 Manufactured03/09/2017
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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