MAUDE Adverse Event Report: COCHLEAR LTD CP1000 MAGNET (2 M, SAND); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1000 ACC

Device Problem Missing Value Reason (3192)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the patient experienced a breakdown of the skin at the processor magnet site, due to the magnet strength of the coil.Subsequently, the magnet strength was reduced and the patient received treatment of oral and topical antibiotics (date not reported).The patient continues to be clinically managed by their healthcare provider.

• Brand Name: CP1000 MAGNET (2 M, SAND)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 6975082
• MDR Text Key: 90147134
• Report Number: 6000034-2017-01994
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036917
• UDI-Public: (01)09321502036917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1000 ACC
• Device Lot Number: Z586147
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization