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

Model Number MI1200 SYNCHRONY PIN

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

Patient Problem No Information (3190)

Event Date 12/19/2018

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

The electrode migrated into the external ear canal.The recipient was implanted with a new device.No product deficiency is alleged.

Event Description

Reportedly, the active electrode migrated into the external ear canal.The recipient was implanted with a new device with the same electrode type on (b)(6) 2018.Despite repeated requests, no further information has been received with regards to the circumstances leading to explantation.

Manufacturer Narrative

Based on the limited information received from the field, the recipient was explanted of the device due to the active electrode having moved to the external ear canal for undetermined reasons.Neither further information nor the explanted device have been received for investigation.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: 8205958
• MDR Text Key: 131700465
• Report Number: 9710014-2018-01056
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737310851
• UDI-Public: (01)09008737310851
• 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
• Report Date: 04/10/2019

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR