MAUDE Adverse Event Report: COCHLEAR LTD CP910 PROCESSING UNIT (MAIZE); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CP910
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on october 25, 2019.
Event or Problem Description
Per the clinic, the patient developed a wound infection at the magnet site of the external processor.The patient was treated with antibiotics and anti-inflammatory medication and the issue has resolved (date not reported).

• Brand Name: CP910 PROCESSING UNIT (MAIZE)
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9247808
• Report Number: 6000034-2019-02115
• Device Sequence Number: 3107944
• Product Code: MCM
• UDI-Device Identifier: 09321502021487
• UDI-Public: (01)09321502021487
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: CP910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention