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 06/04/2020

Event Type  Injury  

Event Description

The user reported not hearing well out of the right implant.The user was re-implanted on (b)(6) 2020.Visual inspection of the intact device under the microspore at explantation did not reveal any device damages.

• 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: 10605170
• MDR Text Key: 209129711
• Report Number: 1066702-2020-00066
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094058
• UDI-Public: (01)09008737094058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020,09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 9 YR