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

Model Number AB-5100R

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2015

Event Type  Injury  

Event Description

The patient reportedly experiences shocking sensations with device use.Programming adjustments were made and external equipment was exchanged, however, the issue was not resolved.The patient's device was explanted.The patient was reimplanted with another advanced bionics cochlear device.

• 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, associate ; 12740 san fernando rd; sylmar, CA 91342 ; 6613627624
• MDR Report Key: 4683731
• MDR Text Key: 5640756
• Report Number: 3006556115-2015-00149
• 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
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2000
• Device Model Number: AB-5100R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/1998
• 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: 23 YR