MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ IMPLANT; COCHLEAR IMPLANT

Model Number CI-1400-01

Device Problem Electrical Shorting (2926)

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

Event Date 01/31/2019

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The recipient's device was reportedly explanted due to decreased performance.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

The external visual inspection revealed that the antenna coil was completely detached from the device, and severe surgical tool damage was observed on the bottom cover and seam weld.These anomalies are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock test was unable to be performed due to the damage the device sustained during revision surgery.The damage the device sustained during revision surgery prevented some electrical tests from being performed.The device passed the electrical test performed.The scanning electron microscopy analysis revealed evidence of a small hole in the damaged area of the bottom cover next to the seam weld damage.This damage to the device was sustained during revision surgery.This is an interim 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 external visual inspection revealed that the antenna coil was completely detached from the device, and severe surgical tool damage was observed on the bottom cover and seam weld.These anomalies are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock test was unable to be performed due to the damage the device sustained during revision surgery.Some electrical tests could not be performed due to the damage the device sustained during the revision surgery.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis revealed evidence of a small hole in the damaged area of bottom cover next to the seam weld damage which is believed to have been sustained during revision surgery.The reported complaint of decreased performance could not be verified during this analysis, which was limited in some respects due to the damage the device sustained during the revision surgery.Due to the state of the device most tests were compromised and pinpointing the root cause was not possible.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 90K¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8341965
• MDR Text Key: 136592087
• Report Number: 3006556115-2019-00076
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2007
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR