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

Model Number CI-1600-05

Device Problems Migration or Expulsion of Device (1395); No Audible Prompt/Feedback (2282)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 09/03/2020

Event Type  Injury  

Event Description

The recipient is reportedly experiencing electrode migration.The recipient presents with decreased performance, non-auditory sensations, and pain.A ct revealed electrode contacts outside of the cochlea.Programming adjustments were made, however, the issue did not resolve.Device testing revealed results within normal limits.Revision surgery will be scheduled.

Manufacturer Narrative

The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.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 external visual inspection revealed silicone damage on the top and bottom covers, slices near the fantail, and the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed cut electrode wires near the fantail.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some electrical test from being performed.The device passed the electrical and mechanical tests performed.The device passed the electrical 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.

• 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: 10448116
• MDR Text Key: 204196415
• Report Number: 3006556115-2020-00842
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016857201
• UDI-Public: (01)07630016857201(11)171103(17)201031
• 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: 08/04/2020

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: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: CI-1600-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/29/2020; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR