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

Model Number MI1000 MED-EL CONCERT

Device Problems Device Appears to Trigger Rejection (1524); Device Handling Problem (3265); Migration (4003)

Patient Problems Inflammation (1932); Tissue Damage (2104)

Event Type  Injury  

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

It was initially reported that there was inflammation of the ear canal and a manual cleaning of the canal was performed.In the process the electrode was inadvertently dislocated.As per new information, an extrusion took place prior to the electrode array being pulled out of the cochlea.The recipient was reimplanted.

Manufacturer Narrative

Conclusion: according to the limited information from the field the electrode array was dislocated during an ear cleaning procedure due to an inflammation in the ear canal.The recipient was re-implanted.In addition it is reported that an extrusion took place before the dislocation of the electrode array.However it was not confirmed by the field if an extrusion of the stimulator housing or an extrusion of the electrode array into the external ear canal is meant.The device has not been received despite requested.If the device is received in the future, the case will be re-opened and the device investigated.

Event Description

There was inflammation of the ear canal and a manual cleaning of the canal was performed.In the process the electrode was reportedly inadvertently dislocated.The recipient was reimplanted with a new device on (b)(6) 2019.No device deficiency has been alleged.Despite requests neither the device nor additional information has been received.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Damages found during investigation are attributable to the removal surgery.This finding was expected because according to the limited information received from the field the electrode array was dislocated during an ear cleaning procedure due to an inflammation in the ear canal.In addition it is reported that an extrusion of the electrode array into the external ear canal took place before the dislocation.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.

Event Description

There was inflammation of the ear canal and a manual cleaning of the canal was performed.In the process the electrode was reportedly inadvertently dislocated.The recipient was reimplanted with a new device on (b)(6), 2019.No device deficiency has been alleged.Recipient's hearing performance was reportedly good prior to the event.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 8559924
• MDR Text Key: 143378608
• Report Number: 9710014-2019-00350
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737083632
• UDI-Public: (01)09008737083632
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 08842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR