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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Emotional Changes (1831)
Event Date 06/07/2017
Event Type  Injury  
Event Description

The recipient reportedly experienced psychiatric problems. The recipient's device was explanted. The recipient was not reimplanted. The recipient¿s device will not return to advanced bionics for analysis.

 
Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed. The recipient reportedly recovered from surgery. The recipient's device will not return to advanced bionics for analysis. A review of the device history record was completed and no anomalies were noted. 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
lacey mcdonald
28515 westinghouse place
valencia, CA 91355
MDR Report Key9481776
MDR Text Key171812003
Report Number3006556115-2019-00755
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2013
Device MODEL NumberCI-1400-01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/03/2011
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: 12/17/2019 Patient Sequence Number: 1
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