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

Model Number CI-1600-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Fever (1858); Head Injury (1879); Unspecified Infection (1930); Swelling (2091); Fluid Discharge (2686)

Event Date 11/27/2018

Event Type  Injury  

Event Description

The recipient reportedly experienced recurring infections.On (b)(6) 2018, the recipient presented with a fever and drainage at the incision site.The recipient was prescribed antibiotics.The recipient then experienced a head trauma incident which caused the incision site to bleed and swell.The recipient was prescribed antibiotics.The recipient experienced another head trauma incident.The recipient was admitted to the hospital and administered iv antibiotics for 3 days.The recipient was diagnosed with cellulitis.The recipient was admitted to the hospital once again and administered iv antibiotics for 6 more days.The recipient's device was explanted.

Manufacturer Narrative

The recipient is reportedly healing well.The external visual inspection revealed slices on the top cover and the electrode was severed near the electrode ground ring prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons the device passed the tests performed.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's infection has reportedly resolved.The recipient is doing well.This is the final report.

• Brand Name: HIRES¿ ULTRA IMPLANT
• 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: 8449692
• MDR Text Key: 139797374
• Report Number: 3006556115-2019-00121
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)170615(17)200630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2017
• 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: 13 MO