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

Model Number MI1250 SYNCHRONY 2

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Impaired Healing (2378)

Event Date 03/03/2023

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 user underwent a revision surgery to thin the skin.The user had the head bandage removed and was to receive the audio processor in (b)(6) 2023.However, the user had not been activated because of some pain and the wound was not healing as expected.The device was eventually explanted on (b)(6) 2023.Per operative report, there was a defect in the area of the cranial skin suture and a lot of granulation was found.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.According to the information received from the field the recipient experienced retention issues with a cmd magnet.A skin flap thinning surgery was performed.After the skin flap thinning surgery the recipient had wound healing issues at the implant site and the device was eventually explanted.This is a final report.

Event Description

The user underwent a revision surgery to thin the skin.The skin flap thickness is unknown, and it is thought the skin flap gauge was not used at implantation.The user had the head bandage removed and was to receive the audio processor in mid on (b)(6) 2023.However, the user had not been activated because of some pain and the wound was not healing as expected.The device was eventually explanted on (b)(6) 2023.Per operative report, there was a defect in the area of the cranial skin suture and a lot of granulation was found.

• 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: 16885907
• MDR Text Key: 314732267
• Report Number: 9710014-2023-00385
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737369026
• UDI-Public: (01)09008737369026
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/24/2023
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2020
• 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: 69 YR
• Patient Sex: Male