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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-1400-02H
Device Problem Electrical Shorting (2926)
Patient Problem No Code Available (3191)
Event Date 04/08/2016
Event Type  malfunction  
Event Description
The recipient is reportedly experiencing shorted electrodes and sound quality issues.Revision surgery will be scheduled.
 
Manufacturer Narrative
The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.
 
Manufacturer Narrative
The external visual inspection revealed the electrode was severed at the fantail and near the array prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed breaks along the severed portion of the electrode lead.System lock was verified.The electrode condition prevented several of the electrical tests from being performed.The device passed all of the electrical tests performed.This is an interim report.
 
Manufacturer Narrative
The external visual inspection revealed the electrode was severed at the fantail and near the array prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed breaks along the severed portion of the electrode lead.System lock was verified.The electrode condition prevented several of the electrical tests from being performed.The device passed all of the electrical tests performed.This is an interim report.
 
Manufacturer Narrative
The external visual inspection revealed the electrode was severed at the fantail and near the array prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed sliced electrode wires along the severed portion of the electrode lead.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented several of the electrical tests from being performed.The device passed all of the electrical and mechanical tests performed.A scanning electron microscopy analysis of the electrode revealed damaged parylene on electrode wires where the wires passed the adjacent contact pads of another electrode.The reported complaint of electrode shorts could not be verified during this analysis, which was limited in some respects due to the electrode being cut prior to receipt.However, damage to the parylene wire coating was found on wires inside the array that are consistent with the electrode short locations reported.Although no electrode shorts were electrically verified, the damage could have caused shorts between these adjacent contacts while implanted in the patient's cochlea.A capa has been implemented.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 Key5616140
MDR Text Key44703729
Report Number3006556115-2016-00167
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,health professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2016
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-1400-02H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2016
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2012
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 Age57 YR
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