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

Model Number SONATA

Device Problems Device Operates Differently Than Expected (2913); Output below Specifications (3004)

Patient Problems Bruise/Contusion (1754); Fall (1848); Failure of Implant (1924); Loss of consciousness (2418)

Event Type  Injury  

Event Description

It was reported that the patient had no longer access to sound.Patient's parents reported that toward end of (b)(6) 2015 the patient had a fall and the implant ear got bruised.After this they noticed he was unresponsive.Previously the patient was showing progress in spoken language development.Re-implantation is considered.

Manufacturer Narrative

(b)(4).The device has not been explanted.If it should be explanted, it is to be returned to the mfr for evaluation.When available, a device failure analysis will be submitted as a f/u report.

Manufacturer Narrative

(b)(4).According to the currently available information, it appears the problems with the active electrode are most likely broken wires due to the reported accident.To determine an exact root cause a device investigation of the explanted device is necessary.The complaint will be reopened as and when the device is explanted.

Event Description

It was reported that the patient had no longer access to sound.Patient's parents reported that towards end of (b)(6) v2015 the patient had a fall and the implant ear got bruised.After this they noticed he was unresponsive.Previously the patient was showing progress in spoken language development.Re-implantation is considered but not scheduled yet.

Manufacturer Narrative

The investigation results confirmed that the device has failed due to an external impact to the active electrode.All the problems given in the patient report and the reported trauma appear to match well with this finding.This is a final report.

Event Description

It was reported that the patient no longer had access to sound.Patient_s parents reported that towards end of (b)(6) 2015 the patient had a fall and the implant ear got bruised.After this they noticed he was unresponsive.Previously the patient was showing progress in spoken language development.The patient has been re-implanted.

• 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: 4701798
• MDR Text Key: 5714871
• Report Number: 9710014-2015-00267
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• 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) 09008737042103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2015
• 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: 3 YR