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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-5100H-11A
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2018
Event Type  malfunction  
Event Description
The recipient is reportedly experiencing loss of lock.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
 
Manufacturer Narrative
The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
 
Manufacturer Narrative
The external visual inspection revealed a severed array, as well as a damaged epoxy header region.These anomalies are believed to have occurred during revision surgery.The photographic imaging inspection confirmed severed electrode wires at the epoxy header 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 severed array, as well as a damaged epoxy header region.These anomalies are believed to have occurred during revision surgery.The photographic imaging inspection confirmed severed electrode wires at the epoxy header 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.The manual capacitor leakage test revealed unstable readings due to flooded components.The failure of this device is attributed to excessive moisture through a gross leak at the case-band braze.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
MDR Report Key7712565
MDR Text Key114858687
Report Number3006556115-2018-00335
Device Sequence Number1
Product Code MCM
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,Followup
Report Date 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/01/2005
Device Model NumberAB-5100H-11A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2018
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2003
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 Age16 YR
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