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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS IMPLANT, COCHLEAR

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COCHLEAR LIMITED NUCLEUS IMPLANT, COCHLEAR Back to Search Results
Model Number CI532
Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problem No Code Available (3191)
Event Date 07/17/2017
Event Type  Malfunction  
Event Description

The patient stated device made a lot of noise and unclear sounds. The device was explanted and a new device implanted.

 
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Brand NameNUCLEUS
Type of DeviceIMPLANT, COCHLEAR
Manufacturer (Section D)
COCHLEAR LIMITED
13059 e peakview ave.
centennial CO 80111
MDR Report Key6759748
MDR Text Key81602493
Report Number6759748
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/02/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCI532
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/18/2017
Event Location Home
Date Report TO Manufacturer07/18/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/02/2017 Patient Sequence Number: 1
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