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

Model Number AB-5100H

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 02/14/2016

Event Type  Injury  

Event Description

The recipient reportedly experienced shocking sensations with device use.External equipment was exchanged, however, the issue was not resolved.The recipient's device was explanted.

Manufacturer Narrative

The external visual inspection revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.In addition, the epoxy header was observed damaged.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 all of the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection revealed cracked conductive epoxy joints across multiple channels.The impedance measurements across these connections did not reveal any increased impedance.The failure of this device is attributed to excessive moisture through a gross leak at the case-band braze.This ultimately caused this device to cease functioning.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: nicole birch ; 28515 westinghouse place; valencia, CA 91355 ; 6613621528
• MDR Report Key: 5470624
• MDR Text Key: 39366149
• Report Number: 3006556115-2016-00079
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AB-5100H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• 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: 17 YR