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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 Structural Problem (2506)
Patient Problem Failure of Implant (1924)
Event Date 04/04/2019
Event Type  Injury  
Event Description
The recipient reportedly experienced poor retention post initial implant surgery.External equipment was exchanged in the operating room, however, the issue did not resolve.The recipient's device was explanted.During explant surgery, it was noted that the magnet was partially outside of the silastic lip.The recipient was reimplanted with another advanced bionics cochlear device.
 
Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed top cover silicone damage prior to receipt.This is believed to have occurred during surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.The device passed the tests performed.This is the final report.
 
Manufacturer Narrative
The recipient's activation reportedly went well.
 
Event Description
The recipient's device was explanted due to lock issues post initial implant surgery.External equipment was exchanged, however, the issue did not resolve.During explant surgery, it was noted that the magnet was partially outside of the silastic lip.The recipient was reimplanted with another ab cochlear device.
 
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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
Manufacturer Contact
delilah garcia
28515 westinghouse place
valencia, CA 91355
MDR Report Key8557198
MDR Text Key143302038
Report Number3006556115-2019-00199
Device Sequence Number1
Product Code MCM
UDI-Device Identifier07630016862267
UDI-Public(01)07630016862267(11)190307(17)220228
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
Report Date 04/05/2019
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 Date02/28/2022
Device Model NumberCI-1601-05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/26/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received05/30/2019
06/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2019
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 Age78 YR
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