MAUDE Adverse Event Report: COCHLEAR LTD . NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM; MCM

Model Number ABI541

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

This report is filed february 18, 2016.The implanted device remains.

Event Description

Per the clinic, the internal magnet became dislodged for unknown reasons.The implanted device remains.

Manufacturer Narrative

Per the clinic, the patient underwent revision surgery on (b)(6) 2016 to reposition the internal magnet.The implanted device remains.This report is filed july 8, 2016.

• Brand Name: NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
• Type of Device: MCM
• Manufacturer (Section D): COCHLEAR LTD .; 14 mars rd; lane cove, nsw 2066 ; AS 2066
• Manufacturer Contact: angel wright ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5448654
• MDR Text Key: 39020683
• Report Number: 6000034-2016-00326
• Device Sequence Number: 1
• Product Code: MHE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: 000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ABI541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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