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

Model Number AB-5100R

Device Problem Premature Discharge of Battery (1057)

Patient Problems Headache (1880); Failure of Implant (1924)

Event Date 03/13/2019

Event Type  malfunction  

Event Description

The recipient reportedly elected explant surgery due to poor battery life.The recipient presented with headaches.The recipient's device was explanted.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the fantail was damaged near the epoxy header, and the electrode was sliced along the lead prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection confirmed broken electrode wires at the epoxy header.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.Voltage values at some nodes were elevated.Internal inspection did not reveal any anomalies on internal components.This older device configuration is not currently manufactured.This is the final report.

Manufacturer Narrative

The recipient was reimplanted with another cochlear device.Additional information regarding recipient status will not be provided.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: CLARION¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8624446
• MDR Text Key: 145626098
• Report Number: 3006556115-2019-00277
• 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,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/15/2001
• Device Model Number: AB-5100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR