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U.S. Department of Health and Human Services

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

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ADVANCED BIONICS, LLC HIRES ULTRA IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1600-04
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 09/24/2020
Event Type  Malfunction  
Event Description

Advanced bionics was informed that device testing revealed abnormal results. Programming adjustments were made, however, the issue did not resolve. The recipient's device was explanted. The recipient was reimplanted with another advanced bionics cochlear device.

 
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Brand NameHIRES ULTRA IMPLANT
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
brooke lopez
28515 westinghouse place
valencia, CA 91355
MDR Report Key10645700
MDR Text Key211437118
Report Number3006556115-2020-01118
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
Type of Report Initial,Followup
Report Date 09/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2020
Device MODEL NumberCI-1600-04
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/23/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/07/2017
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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