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

Model Number CI24RE (L24)

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/01/2020

Event Type  Injury  

Event Description

Per the clinic, i twas reported that the patient experienced a loss of residual hearing, resulting in a decrease of benefit with device use.Subsequently, the device was explanted on (b)(6) 2020, and the patient was reimplanted with another cochlear device during the same surgery.

• 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 Key: 10311912
• MDR Text Key: 199977514
• Report Number: 6000034-2020-01906
• Device Sequence Number: 1
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)180109(17)200108
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2020,07/06/2020

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 Date: 01/08/2020
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2020
• Distributor Facility Aware Date: 07/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR