MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA 3D IMPLANT; COCHLEAR IMPLANT

Model Number CI-1601-04

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

Patient Problems Unspecified Infection (1930); Skin Discoloration (2074); Swelling (2091)

Event Date 09/05/2019

Event Type  Injury  

Event Description

The recipient reportedly experienced a skin flap infection.The recipient presented with discoloration, swelling, and scabbing at the incision site.The recipient was admitted to the hospital from (b)(6) 2019 to (b)(6) 2019.The recipient was prescribed antibiotics and steroids.The recipient ceased device use.Due to the persistent skin flap infection, the recipient's device was explanted on (b)(6) 2019.The recipient will be reimplanted at a later date.

Manufacturer Narrative

The recipient is doing well and no longer on medication.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was severed near the array.This is 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.This is the final report.

• Brand Name: HIRES¿ ULTRA 3D 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: 9125252
• MDR Text Key: 163051867
• Report Number: 3006556115-2019-00580
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862250
• UDI-Public: (01)07630016862250(11)190624(17)220531
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2019
• 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: 14 MO