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

Model Number AB-5100R

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

The recipient elected not to proceed with revision surgery.The recipient is believed to have experienced an in-situ failure.A review of the device history record was completed and no anomalies were noted.The recipient remains implanted.This is the final report.

Event Description

The recipient is reportedly experiencing loss of lock due to head trauma.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.

Manufacturer Narrative

The external visual inspection revealed slices at the fantail region.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical tests performed.This is an interim report.

Manufacturer Narrative

The recipient's device was reportedly explanted.The recipient was reimplanted with another cochlear device.

Manufacturer Narrative

The external visual inspection revealed slices at the fantail region.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could be obtained only at certain spacing.The no lock condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.It is believed that the failure of this device is most likely due to a malfunction with the digital chip.The internal inspection did not reveal any anomalies on internal components.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 ; 6613621741
• MDR Report Key: 7423255
• MDR Text Key: 105394794
• Report Number: 3006556115-2018-00130
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2005
• Device Model Number: AB-5100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/08/2018; 06/04/2018; 07/03/2018; 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2003
• 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 Age: 55 YR