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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-1600-05
Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Nausea (1970); Tinnitus (2103); Dizziness (2194)
Event Type  malfunction  
Event Description
The recipient is reportedly experiencing headache, dizziness, tinnitus and nausea with and without device use.Programming adjustments have been made, however the issues did not resolve.A review of the recipient's test data indicated impedance issues.Revision surgery is scheduled.
 
Event Description
The recipient is reportedly experiencing headache, dizziness, tinnitus and nausea with and without device use.Programming adjustments have been made, however the issues did not resolve.A review of the recipient's test data indicated impedance issues.Revision surgery is scheduled.
 
Manufacturer Narrative
The recipient's device was explanted.The recipient was reimplanted with another cochlear device.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
 
Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed torn silicone overmold on the top cover, as well as a severed electrode.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical test performed.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the ultra is no longer distributed.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 IMPLANT
Type of Device
COCHLEAR 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 Key13168847
MDR Text Key285532781
Report Number3006556115-2021-02016
Device Sequence Number1
Product Code MCM
UDI-Device Identifier07630016857201
UDI-Public(01)07630016857201(11)171206(17)201130
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960058
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
1 Device was Involved in the Event
2 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/30/2020
Device Model NumberCI-1600-05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2022
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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