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

Model Number CI-1400-01

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)

Patient Problems Therapeutic Response, Decreased (2271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/04/2021

Event Type  malfunction  

Event Description

The recipient reportedly experienced decreased performance despite device testing results within normal limits.Programming adjustments were made, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

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 tool damage on the top and bottom covers.In addition, the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The device passed the electrical tests performed and the mechanical tests performed.The reported complaint of performance decrease could not be verified during this analysis, which was limited in some respects due to the electrode being damaged prior to receipt.This device passed all of the 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 90K¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: jennifer rhudy ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 11355701
• MDR Text Key: 233968092
• Report Number: 3006556115-2021-00134
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2010
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Male