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

Model Number AB-5100R

Device Problems Moisture Damage (1405); Overheating of Device (1437); Noise, Audible (3273)

Patient Problems Sweating (2444); No Code Available (3191)

Event Type  Injury  

Event Description

The patient reportedly experienced sound quality issues and overly loud stimulation.External equipment was exchanged; however, it did not resolve the issue.Also, the patient experienced sweating at the implant site due to external equipment becoming warm.Explant is being considered.

• Brand Name: CLARION IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 12740 san fernando road; sylmar CA 91342
• Manufacturer Contact: nicole birch, regulatory affairs ; 12740 san fernando road; sylmar, CA 91342 ; 6613621528
• MDR Report Key: 4543700
• MDR Text Key: 5354195
• Report Number: 3006556115-2015-00062
• 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: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2000
• Device Model Number: AB-5100R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/1998
• 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