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

Model Number MI1250 SYNCHRONY 2 PIN

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Bacterial Infection (1735)

Event Date 09/12/2022

Event Type  Injury  

Event Description

The user suffered from an mrsa cellulitis infection over the implant housing.Despite antibiotic treatment there was then around 4mm of extrusion along the interior side of the implant housing.Reportedly the electrode was also visible along the posterior aspect of the mastoid cavity.An explant kit was requested and the device was explanted on the (b)(6) 2022.Further information has been requested.

• 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: 15474572
• MDR Text Key: 300555414
• Report Number: 1066702-2022-00012
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737395421
• UDI-Public: (01)09008737395421
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2022,09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• Device Catalogue Number: 39570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2022
• 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: 66 YR
• Patient Sex: Female