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 Problems Failure of Implant (1924); Vertigo (2134)

Event Date 05/08/2019

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 the beginning of 2019 fluctuations in impedance were noted during expert testing when the electrode lead behind the pinna was touched.At that time the recipient was satisfied with the device.However, in (b)(6) 2019 fluctuations were seen again and re-implantation was decided.

Manufacturer Narrative

Conclusions: damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.Additionally, an incomplete insertion during implantation surgery is noted on the implant registration card (irc).The investigation results appear to match the problems mentioned in the recipient report.This is a final report.

Event Description

In the beginning of 2019 fluctuations in impedance were noted during expert testing when the electrode lead behind the pinna was touched.At that time the recipient was still satisfied with the device.In (b)(6) 2019 fluctuations were seen again and re-implantation was decided.Reimplantation was performed on (b)(6) 2019.

• 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: 8603045
• MDR Text Key: 144816505
• Report Number: 9710014-2019-00394
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737310936
• UDI-Public: (01)09008737310936
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2019
• 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: 64 YR