MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT

Model Number CI-1500-04

Device Problem Insufficient Information (3190)

Patient Problems Facial Nerve Paralysis (1846); Inflammation (1932); Seizures (2063); Hydrocephalus (3272)

Event Date 09/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Event Description

The recipient reportedly experienced post-operative peripheral facial paralysis on the implant side and meningitis.On (b)(6) 2016 the recipient was hospitalized for fever and seizures due to hydrocephalus.The recipient's device was activated.

Manufacturer Narrative

The recipient's facial paralysis is reportedly improving.

Manufacturer Narrative

For the recipient's facial paresis, the recipient's parents are performing exercises with the recipient as instructed by the doctor.

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.Due diligence attempts to obtain additional information regarding treatment and recipient status were unsuccessful.The recipient reportedly remains implanted.This is the final report.

• Brand Name: HIRES 90K¿ ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: rachael perez ; 28515 westinghouse place; valencia, CA 91355 ; 6613627734
• MDR Report Key: 6251537
• MDR Text Key: 64889947
• Report Number: 3006556115-2017-00019
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2017
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• 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: 17 MO