MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K IMPLANT; COCHLEAR IMPLANT

Model Number CI-1400-01

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 07/18/2020

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing intermittency, static sounds, and non-auditory sensations, followed by loss of lock.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.

Manufacturer Narrative

Additional information: section b.3, d.7, & d.10 the recipient's device was reportedly explanted.The recipient was reimplanted with another 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 recipient was reportedly reimplanted with another advanced bionics cochlear device.The external visual inspection revealed the electrode 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 electrode condition prevented an electrical test from being performed.The device passed an electrical test performed.The device failed the residual gas analysis test.It is believed that the failure of the implantable cochlear stimulator device was caused by a loss of hermetic seal, which was concluded from the residual gas analysis data.This ultimately caused the device to cease functioning.This version of the hires device 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 90K IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 10099006
• MDR Text Key: 193292173
• Report Number: 3006556115-2020-00397
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2007
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/11/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR