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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 Device Inoperable (1663)
Patient Problem No Code Available (3191)
Event Date 12/01/2017
Event Type  Malfunction  
Event Description

The recipient is reportedly experiencing loss of lock. Revision surgery will be scheduled.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

The external visual inspection revealed broken antenna coil wires. The photographic imaging inspection confirmed broken antenna coil wires. 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. This device had broken antenna coil wires. 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
6613624711
MDR Report Key7152046
MDR Text Key96061025
Report Number3006556115-2017-00699
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup
Report Date 12/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2014
Device MODEL NumberCI-1400-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/03/2018
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 Manufactured10/26/2012
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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