MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number MI1000 MED-EL CONCERT

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problems Failure of Implant (1924); Tinnitus (2103)

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

In (b)(6) 2017 the user reported to have a very high tinnitus.In situ testing at this moment showed all channels are ok.In (b)(6) 2017 the tinnitus got worse.Latest in situ testing in (b)(6) 2017 showed 9 channels with high impedance and 2 channels involved in a short circuit.Re-implantation is considered.

Manufacturer Narrative

Conclusion: according to the information received, the recipient suffers from tinnitus, which is a known undesired side effect of cochlear implantation, and gradual decline in hearing performance.Additionally, diagnostic imaging shows one basal electrode contact outside the cochlea.Recent in situ measurements indicate a possible damage to the active electrode likely caused by minute device mobility.However, to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.

Event Description

In (b)(6) 2017 the user reported to have a tinnitus, which is also present without wearing the external device.In situ testing at that moment showed a functional device.In (b)(6) 2017, the tinnitus got worse.The user noticed a gradual decrease in hearing performance with the device.Re-implantation is considered but no date has been scheduled yet.

Manufacturer Narrative

Conclusion: according to the information received, the recipient suffers from tinnitus, which is a known undesired side effect of cochlear implantation, and gradual decline in hearing performance.Additionally, diagnostic imaging shows one basal electrode contact outside the cochlea.Recent in situ measurements indicate a possible damage to the active electrode likely caused by minute device mobility.However, to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.As per additional information received the recipient was explanted and re-implanted on the contralateral site.However the device has not been received for investigation.The above mentioned results still apply.If the device is received in the future, the case will be re-opened and the device investigated.This is a final report.

Event Description

In (b)(6) 2017 the user reported to have a tinnitus, which is also present without wearing the external device.In situ testing at that moment showed a functional device.In (b)(6) 2017, the tinnitus got worse.The user noticed a gradual decrease in hearing performance with the device.The user has been reimplanted on the contralateral side.

Manufacturer Narrative

Conclusion: damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.Other damaged found during investigation are attributable to the explantation surgery.In addition the recipient suffers from tinnitus, which is a known undesired side effect of cochlear implantation and is also present without the use of the external device.Furthermore diagnostic imaging shows one basal electrode contact outside the cochlea.The problems given in the recipient report appear to match the damage found.This is a final report.

Event Description

In (b)(6) 2017 the user reported to have a tinnitus, which is also present without wearing the external device.In (b)(6) 2017, the tinnitus got worse.The user noticed a gradual decrease in hearing performance with the device.The user was explanted of the device on (b)(6) 2018.

• Brand Name: MED-EL MAESTRO 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: 7137654
• MDR Text Key: 95817049
• Report Number: 9710014-2017-001083
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2019

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: MI1000 MED-EL CONCERT
• Other Device ID Number: (01) 09008737062682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 12/19/2017; 12/19/2017; 12/19/2017
• Supplement Dates FDA Received: 02/15/2018; 05/16/2019; 10/03/2019
• 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: 67 YR