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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES ULTRA 3D IMPLANT COCHLEAR IMPLANT

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ADVANCED BIONICS, LLC HIRES ULTRA 3D IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1601-05
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 10/23/2020
Event Type  Injury  
Event Description

The recipient is reportedly a poor performer. Device testing revealed abnormal results. Revision surgery is under consideration.

 
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Brand NameHIRES ULTRA 3D 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 Key10511798
MDR Text Key207291766
Report Number3006556115-2020-00955
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberCI-1601-05
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/28/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/04/2019
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: 09/09/2020 Patient Sequence Number: 1
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