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

Model Number CI-1600-05

Device Problems Material Protrusion/Extrusion (2979); Appropriate Term/Code Not Available (3191)

Patient Problem Wound Dehiscence (1154)

Event Date 07/10/2020

Event Type  Injury  

Event Description

The recipient reportedly experienced device extrusion and a wound.The recipient presented with dehiscence.The recipient's device was explanted.The recipient was not reimplanted.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone slices on the top cover and the electrode was severed at the fantail and along the lead prior to receipt.These are believed to have occurred during revision surgery.The device passed 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.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Additional information: a.3, b.3, & d.7 the recipient was given oral antibiotics for two weeks prior to revision surgery.No other medical intervention was necessary.The recipient is in the process of healing.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: 10311917
• MDR Text Key: 199979152
• Report Number: 3006556115-2020-00671
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016857201
• UDI-Public: (01)07630016857201(11)180523(17)210430
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: CI-1600-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR