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

Model Number AB-5100R

Device Problems Premature Discharge of Battery (1057); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number: na.

Event Description

The recipient reportedly experienced poor battery life and decreased performance.The recipient elected to undergo revision surgery.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

The external visual inspection revealed that the silastic overmold was cut at the electrode lead.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed severed electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed all of the electrical tests performed.The device failed the residual gas analysis test.The reported complaint of patient decrease in performance could not be verified during this analysis, which was limited in some respects due to the condition of the electrode prior to receipt.The device passed all of the electrical tests performed.However, the device had moisture content that exceeded the residual gas analysis test limit.Based on an assessment of the residual gas analysis data it is believed that this device was not hermetic.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; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: delilah garcia ; 28515 westinghouse place; valencia, CA 91355 ; 6613624711
• MDR Report Key: 6814583
• MDR Text Key: 83424902
• Report Number: 3006556115-2017-00460
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/06/2000
• Device Model Number: AB-5100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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: 22 YR