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 Unspecified Infection (1930); Swelling (2091)

Event Date 06/01/2019

Event Type  Injury  

Event Description

The recipient reportedly experienced an infection.The recipient presented with swelling.The recipient's device was explanted.The recipient was not reimplanted at this time.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient has reportedly healed.This is the final report.

Manufacturer Narrative

The recipient was reportedly hit on the head by a piece of board around (b)(6) 2019.The recipient experienced pain and tenderness with discharge at the incision site.The recipient was placed on clindamycin.On (b)(6) 2019, the doctor removed a wood fragment embedded in the skin and an infection was noted.The recipient was switched to cipro 2 times a day with topical clindamycin.On (b)(6) 2019, the recipient attended a follow-up appointment where swelling and discharge was still noted.The recipient was directed to continue cipro until explant surgery.The recipient continued attending follow-up visits to be monitored.The recipient has not experienced any further complications since removing the device.The recipient will be reimplanted once the site has healed.The external visual inspection revealed silicone damage on the top and bottom covers 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.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES¿ ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8879226
• MDR Text Key: 153838490
• Report Number: 3006556115-2019-00469
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)170524(17)200531
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2020
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/26/2019; 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR