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

Model Number CI-1601-05

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Tinnitus (2103); No Code Available (3191)

Event Date 06/26/2020

Event Type  Injury  

Event Description

The recipient is reportedly experiencing poor performance.The recipient is presenting with tinnitus, non-auditory sensations and pain with and without device use.The surgeon referred the recipient to neurology, and placed the recipient on bactrim proactively to treat any possible infection present.Recipient ceased device use.

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient's issues are reportedly not believed to be device related.The recipient resumed device use despite being recommended to cease device use.The recipient was given medication for the pain.The recipient is experiencing heat at the magnet site and a popping sensation.On (b)(6) 2020, the recipient received a post-auricular nerve block shot.Programming adjustments were made, however, the issue did not resolve.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient continues to experience pain, despite treatment.Revision surgery will be scheduled.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Additional information: sections b.3 & d.7 the recipient's device was reportedly explanted.The recipient will not be reimplanted at this time.The recipient has healed from surgery and the pain has resolved.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Correction: section b.3.Advanced bionics considers the investigation into this reportable event as closed.Additional treatment details will not be provided.The external visual inspection revealed the array was severed prior to receipt.This is 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 version of ultra is no longer distributed.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 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 10004948
• MDR Text Key: 189584329
• Report Number: 3006556115-2020-00320
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862267
• UDI-Public: (01)07630016862267(11)190618(17)220531
• 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,Followup,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR