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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT
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ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT Back to Search Results
Model Number CI-1500-04
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 12/27/2016
Event Type  Injury  
Event Description
The recipient is reportedly experiencing pain with device use.Revision surgery has been scheduled.
 
Manufacturer Narrative
(b)(4).The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
 
Manufacturer Narrative
The device passed both the external visual and photographic imaging inspections.System lock was verified.The device passed all of the electrical tests performed.This is an interim report.
 
Manufacturer Narrative
The device passed both the external visual and photographic imaging inspections.System lock was verified.The device passed all of the electrical and mechanical tests performed.This is an interim report.
 
Manufacturer Narrative
The device passed both the external visual and photographic imaging inspections.System lock was verified.The device passed all of the electrical and mechanical tests performed.The device passed all of the tests performed.
 
Manufacturer Narrative
(b)(4).Prior to explantation, external equipment was exchanged and programming adjustments were made, however, the recipient's pain did not resolve.Advanced bionics considers the investigation into this reportable event as closed.The recipient's pain is reportedly resolved.This is the final report.
 
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Brand Name
HIRES 90K¿ ADVANTAGE IMPLANT
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
rachael perez
28515 westinghouse place
valencia, CA 91355
6613627734
MDR Report Key6214283
MDR Text Key63586941
Report Number3006556115-2016-00578
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
PMA/PMN Number
P960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/31/2016
Device Model NumberCI-1500-04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/29/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received01/19/2017
03/07/2017
04/05/2017
04/26/2017
07/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2015
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 Outcome(s) Required Intervention;
Patient Age61 YR
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