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

Model Number C40+

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect which is expected to have been present whilst implanted or would explain the observed problems.Damages found during investigation are attributable to the removal surgery.According to the limited information received from the field the device was explanted because of poor performance and twitching of the temporal muscle with use of the device.As per additional information received the recipient had meningitis whilst implanted with the concerned device.Meningitis may cause ongoing fibrosis of the cochlea, increasing the risk of facial nerve stimulation (fns), as well as damage to the cochlear spiral ganglia, which may result in failure of the neuronal response even in cases of full electrode insertions.Therefore, in the present case, also given the time correlation with the meningitis episode, the reported fns and poor outcomes might be associated with post-meningitic structural changes of the cochlea.This hypothesis is supported further by the fact that performance did not improve after reimplantation with a new device.This is a combined initial and final report.

Event Description

The device has been explanted.According to the device explantation report form the temporal muscle was twitching when the device was in use.The recipient was re-implanted on (b)(6) 2019.

• 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: 10559794
• MDR Text Key: 207709866
• Report Number: 9710014-2020-00515
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: C40+
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2020
• 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: 22 YR