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

Model Number CI-1400-01

Device Problems Improper Device Output (2953); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hearing Impairment (1881); Injury (2348)

Event Date 03/19/2015

Event Type  Injury  

Event Description

The company was informed that the patient's device was explanted due to medical issues and poor performance.The patient was not reimplanted with another cochlear device.Advanced bionics is in the process of gathering more information.Once additional information is received a supplemental report will be submitted.

Manufacturer Narrative

The external visual inspection revealed the silastic overmold was cut near the electrode ground ring sleeve 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.The device passed the tests performed.No corrective action is indicated.This is the final report.

• Brand Name: HIRES 90K IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS LLC; 12740 san fernando rd; sylmar CA 91342 0000
• Manufacturer Contact: nicole birch, associate ; 6613621528
• MDR Report Key: 4808048
• MDR Text Key: 5832440
• Report Number: 3006556115-2015-00251
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,foreign
• Reporter Occupation: No Information
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2015

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: 02/28/2008
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/26/2015; 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2006
• 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 Outcome(s): Required Intervention
• Patient Age: 28 YR