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

Model Number SONATA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient complained that a sharp and loud noise induced an unpleasant feeling in the region between the ear and neck.It was also reported that the patient perceived no distorted sounds, but has less speech understanding.External parts were checked.Latest in situ measurements showed 5 channels involved in 2 short circuits.An accident tor trauma is not known.

Manufacturer Narrative

According to the information from the field, the patient had 3 electrode channels involved in a short circuit since first fitting.Additionally, over time 2 more electrode channels were affected by a short circuit.In house measurements show the device to be within specifications.Therefore it is assumed that the active electrode was inadvertently damaged during the implantation surgery.However to confirm the root cause an investigation at the explanted device will be necessary.The clinic is considering reimplantation with possibly a short and stiffer electrode.However, no date for re-implantation surgery has been scheduled yet.

Event Description

The patient complained that a sharp and loud noise induced an unpleasant feeling in the region between the ear and neck.It was also reported that the patient perceived no distorted sounds, but had less speech understanding.External parts were checked.An accident tor trauma is not known.A re-implantation with a short and stiffer electrode is considered, but no date has been scheduled yet.

Manufacturer Narrative

Additional information: according to the information from the field, the patient had 3 electrode channels involved in a short circuit since first fitting.Additionally, over time 2 more electrode channels were affected by a short circuit.In house measurements show the device to be within specifications.Therefore it is assumed that the active electrode might have been inadvertently damaged during the implantation surgery.As per ct scan, the electrode array was not properly seated in the cochlea.It reached reportedly only halfway of the basal turn.Due to the electrode type chosen (compressed electrode), the cochlea anatomy might be a contributory factor.The patient has been re-implanted, but the device has not been received for investigation despite several requests.There is the suspicion that it was lost.If the device is received in the future, the case will be re-opened and the device investigated.

Event Description

The patient complained that a sharp and loud noise induced an unpleasant feeling in the region between the ear and neck.It was also reported that the patient perceived no distorted sounds, but had less speech understanding.External parts were checked.An accident tor trauma is not known.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: 5334246
• MDR Text Key: 34648061
• Report Number: 9710014-2015-00923
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• 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) 09008737042110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2015
• 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: 59 YR