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

Model Number MI1200 SYNCHRONY

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Seroma (2069); Swelling/ Edema (4577)

Event Date 05/25/2021

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

Reportedly the swelling was observed over the magnet on the implanted left side.Swelling becomes more prominent when wearing the audioprocessor.The user was explanted on the (b)(6) 2021.

Event Description

Reportedly the swelling was observed over the magnet on the implanted left side.Swelling becomes more prominent when wearing the audio-processor.The user was explanted on (b)(6)2021.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received, the recipient experienced postoperative recurrent swelling with no obvious predisposing factors at the implant site that sometimes solved spontaneously or with minimal intervention (i.E.Antibiotic treatment).No evidence of infection has been reported and the recipient did not feel pain and was willing to use the device.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
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 12481247
• MDR Text Key: 271699948
• Report Number: 9710014-2021-00693
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2021
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2018
• 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: 3 YR
• Patient Sex: Female