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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24 CONTOUR; COCHLEAR BAHA ATTRACT SYSTEM
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COCHLEAR LTD NUCLEUS 24 CONTOUR; COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number CI24R (CS)
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 06/10/2020
Event Type  malfunction  
Manufacturer Narrative
This report is submitted on (b)(6) 2020.
 
Event Description
Per the clinic, the patient experienced a performance decrement with device use resulting in an elective explant of the device on (b)(6) 2020.The patient was re-implanted with a new device during the same surgery.
 
Manufacturer Narrative
Correction: date of awareness should be 5 june 2020 not 15 may 2020 as previously reported.This report is submitted on 10 august 2020.
 
Event Description
Correction: date of awareness should be 5 june 2020 not 15 may 2020 as previously reported.
 
Manufacturer Narrative
This report is submitted on 11 september 2020.
 
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Brand Name
NUCLEUS 24 CONTOUR
Type of Device
COCHLEAR BAHA ATTRACT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
MDR Report Key10216162
MDR Text Key197214808
Report Number6000034-2020-01692
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 08/10/2020,08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCI24R (CS)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2020
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/10/2020
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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