MAUDE Adverse Event Report: ADVANCED BIONICS, LLC; COCHLEAR IMPLANT

Device Problem Malposition of Device (2616)

Patient Problems Vertigo (2134); Vomiting (2144)

Event Type  Injury  

Event Description

The recipient reportedly experienced an incorrect electrode position.The recipient presented with vertigo and vomiting.The recipient underwent electrode repositioning surgery.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The insertion of the array into the vestibule initially was attributed to the faulty cochleostomy superior and slightly posterior to the post pillar of the round window niche.Additional information regarding recipient and device details are not available.This is the final report.

• Brand Name: NI
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: delilah garcia ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 8831255
• MDR Text Key: 152339940
• Report Number: 3006556115-2019-00474
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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