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

Model Number MI1000 MED-EL CONCERT

Device Problem Output Problem (3005)

Patient Problems Head Injury (1879); Failure of Implant (1924)

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

The parents reported that since the beginning of (b)(6) 2020 the user has not been hearing with the device.In (b)(6) 2019 a head trauma occurred.The user spent two days at the hospital and subdural hematoma was diagnosed via ct scan.

Manufacturer Narrative

Additional information: based on currently available information, a head trauma was observed.Thus, mechanical damage of the stimulator housing appears likely, being possibly attributable to a severe external impact to the housing.However, to confirm an exact root cause of failure a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.

Event Description

The parents reported that since the beginning of (b)(6) 2020 the user has not been hearing with the device.In november 2019 a head trauma occurred.The user spent two days at the hospital and subdural hematoma was diagnosed via ct scan.Re-implantation is considered but no date has been scheduled yet.

Manufacturer Narrative

Conclusions: the device investigation revealed mechanical damage to the stimulator electronics that is typical for severe external impact to the housing.The problems described in the recipient report and the reported accident appears to match the damage found.This is a final report.

Event Description

The parents reported that since the beginning of (b)(6) 2020 the user has not been hearing with the device.In (b)(6) 2019 a head trauma occurred.The user spent two days at the hospital and subdural hematoma was diagnosed via ct scan.There was no swelling on the region.The user has been re-implanted on (b)(6) 2021.

• 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: 10598852
• MDR Text Key: 208926430
• Report Number: 9710014-2020-00546
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

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: Lay User/Patient
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 08842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 09/21/2020; 09/21/2020
• Supplement Dates FDA Received: 12/14/2020; 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR