MAUDE Adverse Event Report: ADVANCED BIONICS LLC CLARION IMPLANT; COCHLEAR IMPLANT

Model Number AB-5100R

Device Problem Nonstandard Device (1420)

Patient Problem Pain (1994)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

The pt reportedly ceased use of the device due to pain with device use.Testing showed the device was not functioning within specification.Revision surgery is under consideration.

Manufacturer Narrative

The patient is reportedly doing well.The external visual inspection of the device 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 some of the electrical tests from being performed.The device passed some of the electrical tests performed.This is an interim report.

Manufacturer Narrative

The pt's device was explanted.

Manufacturer Narrative

The external visual inspection revealed that 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 some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.It is believed that the failure of this device is most likely due to a malfunction within the analog chip.Internal inspection did not revealed any anomalies on internal components.This older device configuration is no longer manufactured.This is the final report.

• Brand Name: CLARION IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS LLC; 12740 san fernando rd; sylmar CA 91342
• Manufacturer Contact: pamela campo ; 28515 westinghouse place; valencia, CA 91355 ; 6613627624
• MDR Report Key: 4580107
• MDR Text Key: 5451882
• Report Number: 3006556115-2015-00074
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/1999
• Device Model Number: AB-5100R
• Other Device ID Number: N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/1997
• 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: 23 YR