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

Model Number C40+

Device Problems Circuit Failure (1089); Output Problem (3005)

Patient Problems Failure of Implant (1924); Vertigo (2134)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

On (b)(6) 2019, the user reported a sudden loud noise and then having pain and vertigo sensations when using the implant.The pain occurs only when the device is stimulated.Re-implantation is considered.

Manufacturer Narrative

Conclusion: device investigation confirmed that the stimulator electronics is not working according to specifications.The failure of the electronic circuitry was probably caused by humidity ingress at detected micro-leaks at the housing braze joint.Over a certain period of time, humidity will impinge on the electronics and cause damage, potentially leading to complete failure of the circuitry.The problems described in the recipient report appear to match the damage found.Other mechanical damages found during investigation are attributable to the removal surgery.This is a final report.

Event Description

On (b)(6) 2019, the user reported a sudden loud noise and then having pain and vertigo sensations when using the implant.The pain occurs only when the device is stimulated.

• Brand Name: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 8627521
• MDR Text Key: 145631527
• Report Number: 9710014-2019-00416
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: C40+
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR