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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-1601-04
Device Problems Output Problem (3005); Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2020
Event Type  malfunction  
Event Description
The recipient is reportedly experiencing decreased performance.Revision surgery will be scheduled.
 
Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.Legal proceedings have prohibited the testing and failure analysis of the explanted device.As a result, no conclusion can be drawn at this time.If the legal proceedings allow for the analysis to be completed, the issue will be re-opened and the results of the analysis will be reported.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
 
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Brand Name
HIRES ULTRA 3D IMPLANT
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
MDR Report Key10339384
MDR Text Key202001898
Report Number3006556115-2020-00711
Device Sequence Number1
Product Code MCM
UDI-Device Identifier07630016862250
UDI-Public(01)07630016862250(11)190308(17)220228
Combination Product (y/n)N
PMA/PMN Number
P960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/28/2022
Device Model NumberCI-1601-04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age32 MO
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