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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS LLC COCHLEAR IMPLANT HIRES 90K ADVANTAGE; IMPLANT, COCHLEAR
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ADVANCED BIONICS LLC COCHLEAR IMPLANT HIRES 90K ADVANTAGE; IMPLANT, COCHLEAR Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Pain (1994)
Event Date 12/01/2017
Event Type  Injury  
Event Description
On (b)(6) 2017, my son (age (b)(6) at the time) was saying his advance bionic implant was not working.After we tested it and changed the batteries, we placed it on him and he screamed in pain and took it off.After many more attempts, we went to our audiologist the following monday and they ran some tests, couldn't determine what was happening.Went back two days later and met with an advanced bionic's engineer who did an integrity test and concluded the ground electrode was not working properly and the electrical charge was leaving the implant and hitting the surrounding tissue (essentially shocking my son).They changed the path that the charged goes too, avoiding the damaged one and his implant works fine now.But he still can't use that implanted size at its full potential.These implants are supposed to last a lifetime not only 4 years.Fda safety report id# (b)(4).
 
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Brand Name
COCHLEAR IMPLANT HIRES 90K ADVANTAGE
Type of Device
IMPLANT, COCHLEAR
Manufacturer (Section D)
ADVANCED BIONICS LLC
MDR Report Key9260431
MDR Text Key164831179
Report NumberMW5090784
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age5 YR
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