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

Model Number SONATA

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Tissue Damage (2104); Skin Tears (2516)

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 electrode was exposed in the lateral ear canal.It extruded through the skin into the ear canal.Surgery was performed on (b)(6) 2019 where the ear channel was closed and a new device was implanted.The former device was functional and without damage before the surgery.During the explanation, the silicone of the housing was slightly damaged.

Manufacturer Narrative

Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.This finding was expected, because according to the recipient report the active electrode extruded through the lateral ear canal, leading to device explantation for prophylactic reasons.Damages found during investigation are attributable to the removal surgery.This is a final report.

Event Description

Reportedly, the electrode was exposed in the lateral ear canal.It extruded through the skin into the ear canal.Surgery was performed on (b)(6) 2019 where the ear channel was closed and a new device was implanted.The former device was functional and without damage before the surgery.During the explanation the silicone of the housing was slightly damaged.There was no allegation against the device.

• 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: 8987527
• MDR Text Key: 157287285
• Report Number: 9710014-2019-00678
• Device Sequence Number: 1
• Product Code: MCM
• 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: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 77 YR