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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD . NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM; PGQ
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COCHLEAR LTD . NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM; PGQ Back to Search Results
Model Number CI24RE (L24)
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Headache (1880); Pain (1994); Dizziness (2194)
Event Date 12/09/2015
Event Type  Injury  
Event Description
Per the clinic, the patient experienced dizziness, headaches and pain with device use.Reprogramming attempts were made; however, the issue could not be resolved.Subsequently on (b)(6) 2015, the device was explanted and the patient was reimplanted with a new device during the same procedure.
 
Manufacturer Narrative
This report is filed may 9, 2016.
 
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Brand Name
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
Type of Device
PGQ
Manufacturer (Section D)
COCHLEAR LTD .
14 mars rd
po box 629
lane cove, nsw 2066
AS  2066
Manufacturer Contact
angel wright
13059 east peakview avenue
centennial, CO 80111
3037909010
MDR Report Key5348250
MDR Text Key35181758
Report Number6000034-2016-00040
Device Sequence Number1
Product Code PGQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
130016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Audiologist
Type of Report Initial,Followup
Report Date 02/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCI24RE (L24)
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/04/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2015
Was Device Evaluated by Manufacturer? Yes
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 Age38 YR
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