MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Model Number C40+

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

It was reported by the recipient's parents that there was a decrease in hearing performance with the device since (b)(6) 2017.No head trauma and no problems of external devices were reported.The patient was re-implanted on (b)(6) 2017.

Manufacturer Narrative

Based on measurements performed on the device whilst it was implanted and during explant investigation, it must be assumed that the explantation was not due to a technical problem.The recipient_s perception was unsatisfactory.During investigation minor damage to the active electrode was found, which does not explain for the reported lack of benefit.A ct scan was performed before the explantation but there was no indication that the electrode had migrated from it's original placement in the cochlea, however during initial implantation surgery one channel was reportedly left out of cochlea.Also this aspect does not explain for the reported symptoms.This is a final report.

Event Description

It was reported by the recipient's parents that there was a decrease in hearing performance with the device since (b)(4) 2017.No head trauma and no problems of external devices were reported.The user was re-programmed and monitored, but there was no improvement.The user was re-implanted.

• Brand Name: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 7141528
• MDR Text Key: 95586532
• Report Number: 9710014-2017-01090
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

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: Health Professional
• Device Model Number: C40+
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 15 YR