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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS HYBRID L24; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM

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COCHLEAR LTD NUCLEUS HYBRID L24; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24RE (L24)
Device Problems Application Program Problem (2880); Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 06/04/2019
Event Type  Injury  
Manufacturer Narrative
This report is submitted on july 1, 2019.
 
Event Description
Per the clinic, the patient experienced poor performance with the device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted (b)(6) 2019, and the patient was reimplanted with a new device during the same surgery.
 
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Brand Name
NUCLEUS HYBRID L24
Type of Device
NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
MDR Report Key8747110
MDR Text Key149621114
Report Number3005900820-2019-01209
Device Sequence Number1
Product Code PGQ
UDI-Device Identifier09321502012089
UDI-Public(01)09321502012089(11)160811(17)180810
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/01/2019,06/10/2019
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 Expiration Date08/10/2018
Device Model NumberCI24RE (L24)
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/01/2019
Distributor Facility Aware Date06/10/2019
Event Location Home
Date Report to Manufacturer06/10/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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