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

Model Number MI1200 SYNCHRONY PIN

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 09/15/2020

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 situ testing showed affected channels and hearing performance with the device is affected.The parent reported that a few weeks ago the child fell out of a carousel and hit his head.The child has auditory impression on the remaining unaffected channels.He is able to still perceive sounds, but speech discrimination is diminished.

Manufacturer Narrative

Conclusion: the investigation results confirmed that the device has failed due to an external impact to the active electrode.All the problems given in the recipient report appear to match well with this finding.This is a final report.

Event Description

In situ testing showed affected channels and hearing performance with the device is affected.The parent reported that a few weeks ago the child fell out of a carousel and hit his head.The child has auditory impression on the remaining unaffected channels.He is able to still perceive sounds, but speech discrimination is diminished.The user has been re-implanted.

• 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: 10599208
• MDR Text Key: 208934218
• Report Number: 9710014-2020-00531
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094058
• UDI-Public: (01)09008737094058
• 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
• Report Date: 12/21/2020

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: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR