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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 Problems Device Stops Intermittently (1599); Power Problem (3010)
Patient Problem No Code Available (3191)
Event Date 02/22/2017
Event Type  malfunction  
Manufacturer Narrative
Udi number: na.
 
Event Description
The recipient reportedly experienced intermittent lock and increased power consumption.External equipment was exchanged and programming adjustments were made, however, the issue was not resolved.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 cut prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection noted silver migration across several electrical components.This is an interim report.
 
Manufacturer Narrative
The external visual inspection revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection noted silver migration across several electrical components.This device had moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.A capa was implemented.Feedthru assemblies from this vendor are no longer used.This is the final report.
 
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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
Manufacturer Contact
rachael perez
28515 westinghouse place
valencia, CA 91355
6613627734
MDR Report Key6408380
MDR Text Key70305374
Report Number3006556115-2017-00119
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 Audiologist
Type of Report Initial,Followup,Followup
Report Date 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/30/2007
Device Model NumberCI-1400-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2017
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2005
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 Age13 YR
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