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

Model Number CI-1601-04

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

Patient Problems Head Injury (1879); Therapeutic Effects, Unexpected (2099)

Event Date 08/19/2020

Event Type  Injury  

Event Description

The recipient reportedly experienced no auditory response to stimulation despite device testing within normal limits.The lack of response is not believed to be device related.The device was implanted near the auriculae due to the recipient's acoustic neuroma condition.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

Additional information: section d.10 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 at the magnet pocket, top and bottom covers, and near the array.In addition, the electrode ground ring was migrated prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires at the fantail and near the electrode ground ring.These are believed to have occurred during revision surgery.System lock was verified.The device passed the electrical test performed.The residual gas analysis could not be performed due to damage during failure analysis.This device was explanted for medical reasons.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 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 10518186
• MDR Text Key: 206486729
• Report Number: 3006556115-2020-00937
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016870255
• UDI-Public: (01)07630016870255(11)190523(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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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-1601-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR