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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC CLARION¿ IMPLANT; COCHLEAR IMPLANT
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ADVANCED BIONICS, LLC CLARION¿ IMPLANT; COCHLEAR IMPLANT Back to Search Results
Model Number AB-5100L
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2017
Event Type  malfunction  
Event Description
The recipient reportedly experienced loss of lock.External equipment was exchanged and programming adjustments were made, however, the issue is not resolved.Revision surgery will be scheduled.
 
Manufacturer Narrative
The recipient's device was explanted.The recipient was reimplanted with another cochlear device.
 
Manufacturer Narrative
The external visual inspection revealed a damaged epoxy header and braze region.This is believed to have occurred during revision surgery.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.This is an interim report.
 
Manufacturer Narrative
The external visual inspection revealed a damaged epoxy header and braze region.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device passed an electrical test performed.The device failed the residual gas analysis test.The internal visual inspection revealed that a resistor had a corroded trace.It is believed that the failure of this implantable cochlear stimulator (ics) device was caused by a loss of hermetic seal.This is concluded from the residual gas analysis and dye penetrant data.Moisture admitted into this device through this leak resulted in the corrosion of the resistive film material and the shift in resistance value of a resistor.This ultimately caused the device to cease functioning.This older device configuration is no longer manufactured.This is the final report.
 
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Brand Name
CLARION¿ 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
6613621741
MDR Report Key6839945
MDR Text Key84647226
Report Number3006556115-2017-00483
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,user facility
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/03/1999
Device Model NumberAB-5100L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2017
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/1997
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 Age30 YR
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