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

Model Number CI-1600-05

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 05/23/2021

Event Type  Injury  

Event Description

The recipient reportedly experienced bleeding from external canal after implant surgery on (b)(6) 2021.The recipient was hospitalized.The recipient presented with hemorrhaging in the external auditory canal on (b)(6) 2021.The recipient was given antibiotics which helped reduce the bleeding.There is no evidence that the infection is device related.The recipient was discharged on (b)(6) 2021.The recipient's activation went well.

Manufacturer Narrative

Additional information: sections a.1 & a.2.Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly experienced a hematoma and no infection.The recipient's issues resolved.The recipient has recovered.This is the final report.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: 12081661
• MDR Text Key: 258870563
• Report Number: 3006556115-2021-00853
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016877988
• UDI-Public: (01)07630016877988(11)200811(17)230731
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: CI-1600-05
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR