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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT

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ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT Back to Search Results
Model Number CI-1500-01
Device Problems Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017); Physical Property Issue (3008)
Patient Problem Failure of Implant (1924)
Event Date 12/15/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The patient reportedly experienced an unsuccessful electrode insertion during initial implant surgery.The surgeon was not able to identify the correct place of insertion and after several attempts, the electrode array was damaged.The patient was not implanted.The patient will be implanted in the contralateral side.
 
Manufacturer Narrative
The recipient was implanted on the contralateral side with another advanced bionics cochlear device.
 
Manufacturer Narrative
Add'l info.
 
Manufacturer Narrative
(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The company was informed that the explanted device will not be returned to the company for analysis.A review of the device history record noted no rework.This is the final report.
 
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Brand Name
HIRES 90K¿ ADVANTAGE 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 Key6233377
MDR Text Key64180111
Report Number3006556115-2016-00590
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeIN
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
Report Date 12/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2018
Device Model NumberCI-1500-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/09/2017
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received04/05/2017
05/10/2017
06/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2016
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 Outcome(s) Required Intervention;
Patient Age28 MO
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