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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 Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Impedance Problem (2950)
Patient Problem Insufficient Information (4580)
Event Type  Malfunction  
Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed. It is believed that the recipient experienced an in-situ failure. A review of the device history record was completed and no anomalies were noted. The recipient remains implanted. This is the final report.

 
Event Description

The recipient is reportedly experiencing impedance issues and potential device failure. Device testing results revealed abnormal results. External equipment was exchanged, however, the issue did not resolve. The recipient will not be explanted at this time.

 
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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
alexandra gonzalez
28515 westinghouse place
valencia, CA 91355
MDR Report Key10691325
MDR Text Key213487679
Report Number3006556115-2020-01117
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeDE
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
Report Date 09/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/01/2005
Device MODEL NumberCI-1400-01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/27/2003
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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