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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS® HYBRID¿ S8; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM

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COCHLEAR LIMITED NUCLEUS® HYBRID¿ S8; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24RE (S8)
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2021
Event Type  Injury  
Manufacturer Narrative
This report is submitted on oct 22, 2021.
 
Event Description
Per the clinic, the device was electively explanted on (b)(6) 2021.The patient was reimplanted with another cochlear device during the same surgery.
 
Manufacturer Narrative
Device analysis report is attached.This report is submitted on november 22, 2021.
 
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Brand Name
NUCLEUS® HYBRID¿ S8
Type of Device
NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LIMITED
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
yaneesa vetsandonphong
unit ug-1 vertical podium
no. 8 jalan kerinchi
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key12679176
MDR Text Key277837804
Report Number6000034-2021-03192
Device Sequence Number1
Product Code PGQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/02/2021
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 Lay User/Patient
Device Model NumberCI24RE (S8)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/01/2021
Initial Date FDA Received10/22/2021
Supplement Dates Manufacturer Received11/02/2021
Supplement Dates FDA Received11/21/2021
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 Age56 YR
Patient SexFemale
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