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

Model Number CI-1600-05

Device Problem Material Deformation (2976)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 07/09/2019

Event Type  Injury  

Event Description

The recipient reportedly experienced an incomplete electrode insertion and cerebral spinal fluid leakage due to cochlear malformation.The recipient's device was explanted.The recipient was not reimplanted.The recipient was hospitalized for observation and then discharged.The recipient is in the process of healing.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.Additional details will not be provided.The device passed the external visual and the photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.

Manufacturer Narrative

During initial implant surgery, the recipient reportedly experienced an incomplete electrode insertion and cerebral spinal fluid leakage due to a cochlear malformation.The recipient was discharged from the hospital after a period of surveillance.

• Brand Name: HIRES¿ ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: brooke lopez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 9406451
• MDR Text Key: 169012287
• Report Number: 3006556115-2019-00740
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016844584
• UDI-Public: (01)07630016844584(11)180607(17)210531
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: CI-1600-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2019
• 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; Required Intervention
• Patient Age: 3 YR