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

Model Number AB-5100H-01A

Device Problems Loose or Intermittent Connection (1371); Insufficient Information (3190)

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

Event Date 06/01/2020

Event Type  malfunction  

Event Description

The recipient's device was reportedly explanted.Advanced bionics is in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.Additional information obtained reportedly indicates that the reason for explant was loss of lock.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Additional information: sections h.4, d.4, & d.10 disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.No further details will be provided.The external visual inspection revealed the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical test performed.The device passed the tests performed.This older device configuration is not currently manufactured.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The internal visual inspection revealed that the analog chip was damaged.This was induced during the failure analysis process.The reported complaint of loss of lock could not be confirmed due to damage induced to the hybrid during the failure analysis process.This device passed the limited electrical tests performed.This is the final report.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: 10292399
• MDR Text Key: 199446776
• Report Number: 3006556115-2020-00630
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2004
• Device Model Number: AB-5100H-01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR