MAUDE Adverse Event Report: COCHLEAR LIMITED COCHLEAR OSIA OSI200 IMPLANT; COCHLEAR¿ OSIA¿ SYSTEM

Model Number OSI200

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Per the clinic, the device was explanted (specific date not reported) due to unknown reason.Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Correction: this mdr was a duplicate.Any further information will be provided with report number 6000034-2023-03415.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• Type of Device: COCHLEAR¿ OSIA¿ SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 18207939
• MDR Text Key: 328957328
• Report Number: 6000034-2023-03991
• Device Sequence Number: 1
• Product Code: PFO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2023,12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: OSI200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2023
• Distributor Facility Aware Date: 12/05/2023
• Date Report to Manufacturer: 12/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention