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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ IMPLANT; COCHLEAR IMPLANT
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ADVANCED BIONICS, LLC HIRES 90K¿ IMPLANT; COCHLEAR IMPLANT Back to Search Results
Model Number CI-1400-01
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2019
Event Type  malfunction  
Event Description
The recipient reportedly experienced loss of lock and decreased performance.External equipment was exchanged and 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.
 
Manufacturer Narrative
The external visual inspection revealed the electrode was sliced, damaged, and severed along the lead prior to receipt.In addition, the electrode ground ring was missing.These are believed to have occurred during revision surgery.The photographic imaging inspection confirmed damaged electrode wires along the lead.These are believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed the electrical tests performed.This is an interim report.
 
Manufacturer Narrative
The external visual inspection revealed the electrode was sliced, damaged, and severed along the lead prior to receipt.In addition, the electrode ground ring was missing.These are believed to have occurred during revision surgery.The photographic imaging inspection confirmed damaged electrode wires along the lead.These are believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis at the damaged location along the electrode lead confirmed opens at some electrodes.The reported complaint of intermittencies and decreased performance could not be verified during this analysis, which was limited in some respects due to the electrode being severed and damaged prior to receipt.The device passed the electrical tests performed.This is the final report.
 
Manufacturer Narrative
The external visual inspection revealed the electrode was sliced, damaged, and severed along the lead prior to receipt.In addition, the electrode ground ring was missing.These are believed to have occurred during revision surgery.The photographic imaging inspection confirmed damaged electrode wires along the lead.These are believed to have occurred during revision surgery.The electrode condition prevented some electrical tests from being performed.The device passed the electrical and mechanical tests performed.This is an interim 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 90K¿ IMPLANT
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
MDR Report Key9090168
MDR Text Key164907380
Report Number3006556115-2019-00569
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 health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/28/2014
Device Model NumberCI-1400-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/19/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received10/30/2019
12/09/2019
12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age8 YR
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