MAUDE Adverse Event Report: COCHLEAR LTD. NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM; MCM, PRODUCT CODE: MCM, PRODUCT CODE: MCM

Model Number CI24RE (CA)

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Headache (1880)

Event Date 12/17/2014

Event Type  Injury  

Event Description

Per the clinic, the implant template was left in place during implant surgery.Subsequently on (b)(6) 2014, the patient underwent a surgical procedure to remove the template.The implanted device remains.

Manufacturer Narrative

(b)(4).Implanted device remains.

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
• Type of Device: MCM, PRODUCT CODE: MCM, PRODUCT CODE: MCM
• Manufacturer (Section D): COCHLEAR LTD.; 14 mars rd.; po box 629; lane cove, nsw 2066 ; AS 2066
• Manufacturer Contact: jennifer campo ; 13059 east peakview ave.; centennial, CO 80111 ; 3037909010
• MDR Report Key: 4484099
• MDR Text Key: 5350019
• Report Number: 6000034-2015-00106
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 31 YR