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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD CP1000 MAGNET (3 M); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD CP1000 MAGNET (3 M); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CP1000
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Swelling/ Edema (4577)
Event Type  Injury  
Event Description
Per the clinic, the patient experienced redness and swelling at the magnet site (date not reported).The patient was treated with topical antibiotics (date and duration not reported).The implanted device remains.
 
Manufacturer Narrative
This report is submitted on may 11, 2022.
 
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Brand Name
CP1000 MAGNET (3 M)
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
Manufacturer (Section G)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS   2109
Manufacturer Contact
min, debbie ang
unit ug-1 vertical podium
no. 8 jalan kerinchi
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key14351070
MDR Text Key291342718
Report Number6000034-2022-01562
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCP1000
Device Catalogue NumberZ586153
Was Device Available for Evaluation? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 SexFemale
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