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

Model Number CI-1600-04

Device Problems Electrical Shorting (2926); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 01/29/2019

Event Type  malfunction  

Event Description

The recipient reportedly experienced decreased performance and shorted electrodes.Programming adjustments were made, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

Correction: advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was sliced near the electrode ground ring, along the lead, and along the small tube prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed cut electrode wires along the small tube.These are believed to have occurred during revision surgery.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The scanning electron microscopy analysis revealed no anomalies within the array.The failure of this device can be attributed to electrode shorts in the electrode pocket of the device.A corrective action was initiated.This is the final report.

Manufacturer Narrative

The external visual inspection revealed the electrode was sliced near the electrode ground ring, along the lead and along the small tube prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed cut electrode wires along the small tube.This is believed to have occurred during revision surgery.System lock was verified.The device passed some of the electrical tests performed.This is an interim report.

Manufacturer Narrative

The external visual inspection revealed the electrode was sliced near the electrode ground ring, along the lead and along the small tube prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed cut electrode wires along the small tube.These are believed to have occurred during revision surgery.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical test performed.This is an interim report.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was sliced near the electrode ground ring, along the lead and along the small tube prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed cut electrode wires along the small tube.These are believed to have occurred during revision surgery.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The scanning electron microscopy analysis revealed no anomalies within the array.The failure of this device can be attributed to electrode shorts.A corrective action was initiated.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: HIRES¿ ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8326398
• MDR Text Key: 136282521
• Report Number: 3006556115-2019-00032
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)161213(17)191231
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR