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

Model Number CI-1600-04

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Head Injury (1879); Pain (1994)

Event Type  Injury  

Event Description

The recipient reportedly experienced a head trauma and is presenting with pain, tenderness, and device migration.A x-ray and device testing revealed results within normal limits.Revision surgery will be scheduled.

Manufacturer Narrative

The recipient reportedly experienced the head trauma incident two months before the device testing on (b)(6) 2020.The recipient was treated with antibiotics.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly experienced intermittent issues prior to revision surgery.On october 17, 2020, the recipient underwent repositioning surgery.The recipient has healed and resumed device use.No further details will be provided.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: 10531935
• MDR Text Key: 206860834
• Report Number: 3006556115-2020-00960
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)170224(17)200229
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention