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

Model Number CI-1400-01

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 10/18/2014

Event Type  Injury  

Event Description

The pt's electrode array had reportedly extruded into the ear canal.During an ear cleaning, the ent erroneously extracted the electrode array.The pt's device was explanted.The pt was reimplanted with another advanced bionics cochlear device.

• Brand Name: HIRES 90K IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS LLC; 12740 san fernando rd; sylmar CA 91342
• Manufacturer Contact: pamela campo, ra assoc ; 12740 san fernando rd; sylmar, CA 91342 ; 6613627624
• MDR Report Key: 4276071
• MDR Text Key: 20659777
• Report Number: 3006556115-2014-00560
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CF
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2010
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2008
• 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 Outcome(s): Required Intervention
• Patient Age: 14 YR