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

Model Number MI1200 SYNCHRONY

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 12/26/2018

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 user reported unclear speech perception with the device.She had fallen 4 days prior and hit her head near the implant site.A wound and scratches were noted around the pinna.

Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode, as it might be caused by an external mechanical impact appears likely.An impact is mentioned in the recipient's report.Furthermore channel 12 shows intermittent hi status due to undetermined reasons.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 user reported unclear speech perception with the device.She had fallen 4 days prior and hit her head near the implant site.A wound and scratches were noted around the pinna.Re-implantation has been recommended but a date for surgery has not yet been made available.

Event Description

The user reported unclear speech perception with the device.She had fallen 4 days prior and hit her head near the implant site.A wound and scratches were noted around the pinna.The recipient was re-implanted.

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.

• 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: 8205939
• MDR Text Key: 131708924
• Report Number: 9710014-2018-01054
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Device Catalogue Number: 31093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR