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

Model Number C40+

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 08/04/2017

Event Type  Malfunction  

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

The user reports decline in hearing performance with the device since (b)(6) 2017. No head trauma, no problems with external devices were reported. The recipient's performance was initially fine. As per surgeon, ossification was already present before the first implantation, but not severe. Imaging was done before re-implantation to check the status of the ossification. A prognosis evaluation had been done before the re-implantation of the user. Due to the cochlear ossification it is known that the hearing performance with the device will still be poor if this user was re-implanted on the same side. Following up the suggestion of the surgeon, the previous implant wasn't removed, meanwhile re-implantation was done on the contralateral side on (b)(6) 2017.

Manufacturer Narrative

Conclusions: as per received in situ measurements, damage to the active electrode appears possible. However currently available information does not allow to identify a more specific root cause. Also, the observed growth of cochlea ossification may have contributed to the deterioration of hearing performance with the device and to the changes of impedance values. An investigation of the explanted device is necessary, but there are currently no plans to explant the concerned device. The recipient has been implanted on the contralateral side. This is a final report.

Event Description

The user reports decline in hearing performance with the device since (b)(6) 2017. No head trauma or problems with external devices were reported. The recipient's performance was initially fine. According to the surgeon, the impedance increase was in correspondence with growth of cochlear ossification, which was already present before first implantation but it was not severe. Following up the suggestion of the surgeon, the previous implant was not removed, meanwhile implantation was done on the contralateral side on (b)(6) 2017.

• 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: 7141524
• MDR Text Key: 95586002
• Report Number: 9710014-2017-001093
• 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

• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/22/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: C40+
• OTHER Device ID Number: (01) 09008737015114
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 12/22/2017 Patient Sequence Number: 1