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

Model Number SONATA

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Hearing Loss (1882); Failure of Implant (1924); Partial Hearing Loss (4472)

Event Date 11/27/2014

Event Type  Injury  

Event Description

It was reported by the patient's father the patient suddenly lost access to sound with the device whilst using the computer.In situ measurements showed 11 electrode channels with status hi.An accident or trauma is denied by the parents.Device explantation without re-implantation is wanted by the parents.The patient's surgery will require psychological an language therapist's assessments.

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it is to be returned to the manufacture for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

It was reported by the patient's father that the patient suddenly lost access to sound with the device whilst using the computer.An accident or trauma is denied by the parents.Device explantation without re-implantation is wanted by the parents.The patient's surgeon will require psychological and language therapist's assessments.As per new information received, the patient has not been in contact with the audiologist, or the language therapist.The patient has disappeared.

Manufacturer Narrative

(b)(4).Additional information- based on the received information and test data, damage to the active electrode is suspected i.E.Excessive mechanical stress.The complaint will be re-opened, when further info is received.

Event Description

It was reported by the patient's father that the patient suddenly lost access to sound with the device whilst using the computer.An accident or trauma is denied by the parents.The patient's surgeon will require psychological and language therapist's assessments.Information received on january 30, 2015, the patient has not had contact with the audiologist or the language therapist.The language therapist called him several times but the patient has disappeared.The patient has been re-implanted, but the device has not been made available for investigation.

Manufacturer Narrative

Additional information: the device has not been made available to the manufacturer for examination, so no device investigation was conducted.If the device is received in the future, the case will be re-opened and the device investigated.In accordance with the information in the patient report, damage to the active electrode, as might be caused by an external mechanical impact appears likely.

• 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: 4384641
• MDR Text Key: 5122516
• Report Number: 9710014-2014-00720
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SONATA
• Other Device ID Number: (01) 09008737083618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2014
• 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: 6 YR
• Patient Sex: Male