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

Model Number C40+

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user was involved in a car accident and the trauma caused the device to become loose.As per the physician, the housing feels loose and the device can be moved manually.The audio processor was lost, so it is unknown how the user's hearing performance is.Re-implantation is planned.

Manufacturer Narrative

Additional information: according to the received information from the field, the implant housing became loose and could be moved from its intended position.Reportedly a trauma occurred, which likely contributed to the reported issue.Furthermore, in situ measurements show two channels involved in a short-circuit for undetermined reasons.To determine an exact root cause, device investigation of the explanted device would be necessary.Re-implantation is considered but no date has been scheduled yet.

Event Description

The user was involved in a car accident and the trauma caused the device to become loose.As per the physician, the housing feels loose and the device can be moved manually.The audio processor was lost, so it is unknown how the user's hearing performance is.Re-implantation is planned.

• 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: 18892556
• MDR Text Key: 337550245
• Report Number: 9710014-2024-00232
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• 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 Age: 25 YR
• Patient Sex: Male